CLINICAL TRIALS PROFILE FOR COPPER

505(b)(2) Clinical Trials for COPPER

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT02519231 ↗	Copper IUD Treatment Observation Study	Completed	Cook County Hospital	Phase 4	2016-02-01	Studies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7 days of menstruation for three consecutive cycles, and then observed for one cycle without treatment.
OTC	NCT02519231 ↗	Copper IUD Treatment Observation Study	Completed	Teva Pharmaceuticals USA	Phase 4	2016-02-01	Studies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7 days of menstruation for three consecutive cycles, and then observed for one cycle without treatment.
OTC	NCT02519231 ↗	Copper IUD Treatment Observation Study	Completed	University of Washington	Phase 4	2016-02-01	Studies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7 days of menstruation for three consecutive cycles, and then observed for one cycle without treatment.
New Formulation	NCT04039828 ↗	Zinc Sulfate Acceptability	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	N/A	2019-09-09	Introduction: Zinc (Zn) is an essential mineral widely distributed within the human body with metalloproteins, Zinc-binding proteins, etc. It is necessary for signal transduction and also cell growth and proliferation via respective metallo- and zinc-dependent enzymes. Zinc supplementation can significantly reduce diarrheal severity and duration as well as prevents future incidences and reduces use of other medications in diarrhoea. For this reason WHO, UNICEF, USAID and experts worldwide jointly recommended zinc supplementation (10 mg for infants less than 6 months old and 20 mg in 6 - 59 months old) combined with reduced osmolarity ORS for clinical management of acute diarrhoea. But due to strong metallic taste zinc products are less palatable to children even after using masking flavours as recommended by WHO. Several companies have formulated the product since WHO recommendations came but still transient side effects like vomiting and regurgitation remain evident. Despite careful counselling to the caregivers expected adherence rate to 10 days regimen of zinc supplement is yet to be reached. With the aim to increase zinc supplement coverage during acute diarrheal illness, it is necessary to conduct a study to introduce new formulation Zinc tablet which is more palatable, more dispersible and more acceptable. Intervention: Zinc sulfate [Zinc Dispersible Tablet, 20 mg; (Elemental Zinc 20 mg as Zinc Sulfate Monohydrate / Tablet)] Methods: Prospective, open label, interventional study Hypothesis: Improved formulation of Zinc Sulfate will have good acceptability. Study population: Stratum 1: 3 months - <18 months = 175 children Stratum 2: 18 months - 59 months = 175 children Objectives: 1. Primary Objective: Acceptability of the zinc product in the management of childhood diarrhea will be assessed by observing: i) Incidence of vomiting or regurgitation among enrolled children receiving the improvised zinc formulation. ii) The adherence: The number of days (out of the total 10 days) the child took the protocol-prescribed dose of the medicine. The treatment will be considered to have good acceptability if at least 80% of the prescribed treatment is taken by at least 70% of the children over the duration of 10 days, as per WHO guidelines. 2. Secondary objective : To assess palatability Secondary end point evaluation (Palatability): The statistical analysis will comprise the calculation of the percentage of patients out of 350 who found the investigational product to have "very well-tolerated, well-tolerated or tolerated" scores (i.e. any of the upper 3 possible scores). A 95% confidence interval, using the normal approximation of the binomial distribution, will be calculated for the percentage.
OTC	NCT06016452 ↗	A Study of Chlorophyllin for the Management of Brain Radio-necrosis in Patients With Diffuse Glioma	Recruiting	Bhabha Atomic Research Centre (BARC)	Phase 2	2023-11-13	Diffuse gliomas are common tumors involving the brain. They are usually treated by surgery followed by radiation and chemotherapy. Radiotherapy is used for the treatment of brain tumors which causes damage to the tumor cells. However, radiotherapy can also affect the surrounding healthy cells in the brain, causing inflammation and swelling in the region, which is known as radio necrosis (RN). This is considered a late side effect of radiation and is seen in 10-25% of patients treated with radiation for brain tumors. Sometimes, radionecrosis can be detected on routine imaging during follow-up without new symptoms (asymptomaticRN). At the same time, in some patients, it can give rise to new symptoms like headaches, weakness, seizures,etc (symptomatic RN). The standard treatment of RN includes steroid medicines called dexamethasone, which is helpful in a proportion of patients. This is a prospective phase 2 study. This study is being conducted to investigate the ability of the drug Chlorophyllin in the treatment of radionecrosis. Chlorophyllin is a water-soluble compound obtained from the green plant pigment called chlorophyll. It has been shown to have anti-cancer, anti-bacterial, anti-viral, anti-inflammatory, and antioxidant properties. It is also used as an oral formulation and is an over-the-counter drug in various countries, and also as a food colouring agent. This is the first time chlorophyllin will be used in the setting of brain radionecrosis. Our primary aim of the study is to assess whether CHL will improve the clinical-radiological response rates. This study will be conducted on a population of 118 patients for a duration of 3 months. The total study duration is 2 years. The study is funded by Bhabha Atomic Research Centre (BARC).
OTC	NCT06016452 ↗	A Study of Chlorophyllin for the Management of Brain Radio-necrosis in Patients With Diffuse Glioma	Recruiting	Tata Memorial Centre	Phase 2	2023-11-13	Diffuse gliomas are common tumors involving the brain. They are usually treated by surgery followed by radiation and chemotherapy. Radiotherapy is used for the treatment of brain tumors which causes damage to the tumor cells. However, radiotherapy can also affect the surrounding healthy cells in the brain, causing inflammation and swelling in the region, which is known as radio necrosis (RN). This is considered a late side effect of radiation and is seen in 10-25% of patients treated with radiation for brain tumors. Sometimes, radionecrosis can be detected on routine imaging during follow-up without new symptoms (asymptomaticRN). At the same time, in some patients, it can give rise to new symptoms like headaches, weakness, seizures,etc (symptomatic RN). The standard treatment of RN includes steroid medicines called dexamethasone, which is helpful in a proportion of patients. This is a prospective phase 2 study. This study is being conducted to investigate the ability of the drug Chlorophyllin in the treatment of radionecrosis. Chlorophyllin is a water-soluble compound obtained from the green plant pigment called chlorophyll. It has been shown to have anti-cancer, anti-bacterial, anti-viral, anti-inflammatory, and antioxidant properties. It is also used as an oral formulation and is an over-the-counter drug in various countries, and also as a food colouring agent. This is the first time chlorophyllin will be used in the setting of brain radionecrosis. Our primary aim of the study is to assess whether CHL will improve the clinical-radiological response rates. This study will be conducted on a population of 118 patients for a duration of 3 months. The total study duration is 2 years. The study is funded by Bhabha Atomic Research Centre (BARC).

All Clinical Trials for COPPER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001262 ↗	Copper Histidine Therapy for Menkes Diseases	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2	1990-06-01	Menkes Disease is a genetic disorder affecting the metabolism of copper. Patient with this disease are both physically and mentally retarded. Menkes disease is usually first detected in the first 2-3 months of life. Infant males born with the disease fail to thrive, experience hypothermia, have delayed development, and experience seizures. These infants also have characteristic physical features such as changes of their hair and face. Females may also have changes in hair and skin color, but rarely have significant medical problems. Appropriate treatment of Menkes Disease requires that the disease be diagnosed early and treatment started before irreversible brain damage occurs. The aim of treatment is to bypass the normal route of absorption of copper through the gastrointestinal tract. Copper must then be delivered to brain cells and be available for use by enzymes. Copper histidine is a copper replacement that can be injected directly into the body to avoid absorption through the gastrointestinal tract. However, studies have shown the genetic abnormalities causing Menkes disease cannot simply be corrected by copper replacement injections. The genetic abnormality causing Menkes disease can vary in its severity. Patients with a genetic abnormality that may still permit some production of the enzymes required to process copper may receive benefit from early treatment with copper replacement. However, patients with severe abnormalities of the genes responsible for copper metabolism may receive no benefit from copper replacement. The purpose of this study is to continue to evaluate the effects of early copper histidine in Menkes disease patients and to correlate specific molecular defects with responses to treatment.
NCT00003751 ↗	Penicillamine, Low Copper Diet, and Radiation Therapy in Treating Patients With Glioblastoma	Completed	National Cancer Institute (NCI)	Phase 2	1999-03-01	RATIONALE: Penicillamine may stop the growth of glioblastomas by stopping blood flow to the tumor. A diet low in copper may interfere with the growth of brain tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining these therapies may be effective in treating glioblastoma. PURPOSE: Phase II trial to study the effectiveness of penicillamine, a low copper diet, and radiation therapy in treating patients who have newly diagnosed glioblastoma.
NCT00003751 ↗	Penicillamine, Low Copper Diet, and Radiation Therapy in Treating Patients With Glioblastoma	Completed	Sidney Kimmel Comprehensive Cancer Center	Phase 2	1999-03-01	RATIONALE: Penicillamine may stop the growth of glioblastomas by stopping blood flow to the tumor. A diet low in copper may interfere with the growth of brain tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining these therapies may be effective in treating glioblastoma. PURPOSE: Phase II trial to study the effectiveness of penicillamine, a low copper diet, and radiation therapy in treating patients who have newly diagnosed glioblastoma.
NCT00003751 ↗	Penicillamine, Low Copper Diet, and Radiation Therapy in Treating Patients With Glioblastoma	Completed	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2	1999-03-01	RATIONALE: Penicillamine may stop the growth of glioblastomas by stopping blood flow to the tumor. A diet low in copper may interfere with the growth of brain tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining these therapies may be effective in treating glioblastoma. PURPOSE: Phase II trial to study the effectiveness of penicillamine, a low copper diet, and radiation therapy in treating patients who have newly diagnosed glioblastoma.
NCT00004338 ↗	Study of Zinc for Wilson Disease	Completed	University of Michigan	Phase 4	1993-10-01	OBJECTIVES: I. Establish the safety and efficacy of extended maintenance zinc therapy in 200 patients with Wilson disease. II. Establish further the role of zinc in the prophylactic treatment of presymptomatic patients by increasing the current cohort from 80 to at least 100 patients. III. Establish further the role of zinc therapy in pregnant patients with Wilson disease. IV. Establish further the role of zinc therapy in children with Wilson disease.
NCT00004338 ↗	Study of Zinc for Wilson Disease	Completed	National Center for Research Resources (NCRR)	Phase 4	1993-10-01	OBJECTIVES: I. Establish the safety and efficacy of extended maintenance zinc therapy in 200 patients with Wilson disease. II. Establish further the role of zinc in the prophylactic treatment of presymptomatic patients by increasing the current cohort from 80 to at least 100 patients. III. Establish further the role of zinc therapy in pregnant patients with Wilson disease. IV. Establish further the role of zinc therapy in children with Wilson disease.
NCT00006332 ↗	Treatment of Hepatocellular Carcinoma With Tetrathiomolybdate	Completed	National Center for Research Resources (NCRR)	Phase 2	1969-12-31	Hepatocellular carcinoma (HCC) is a deadly tumor for which the incidence is increasing in the United States, primarily due to prevalence of hepatitis C infection. An important aspect of the development of HCC is that it occurs in patients who have underlying cirrhosis of the liver, thereby limiting the therapeutic options. There is potential curative treatment for these patients, such as resection of the tumor lesion and liver transplantation, but these treatments are feasible in a small percent of patients only. Furthermore, the majority of the patients with HCC are also not candidates for palliative treatments such as percutaneous ablation of the tumor, chemotherapy or radiation. Additionally, it has been shown that these palliative treatment modalities do not alter survival, and are associated with significant risks. Therefore, there are no treatment options for most patients with HCC. A new theory has emerged in the fight against cancer through inhibition of angiogenesis (development of new blood vessels). The hypothesis being that if there is no blood supply "feeding" the tumor cells cannot divide or survive. One such approach, pioneered in this institution by Drs. George Brewer and Sofia Merajver, is the anticopper approach using the medication tetrathiomolybdate (TM). By creating a mild copper deficiency state, several pathways required for angiogenesis are inhibited. They performed a Phase I trial in which patients with metastatic cancer were treated with TM resulting in decrease tumor vascularity. TM had excellent safety profile in this patient population. HCC is well known to be a hypervascular tumor. An antiangiogenesis approach might provide a novel treatment for this HCC. This is a pilot study of 10 patients with HCC who are not candidates for curative surgical therapy with resection or liver transplantation, nor for ablative techniques. Patients seen in the General Liver clinic and Liver Transplant clinic who have an overall good performance status, with an expected survival of more than 6 months will be enrolled. After an initial evaluation, they will be given 120 mg/day of TM in divided doses for one year. The size and vascularity of the tumor will be evaluated by magnetic resonance imaging (MRI). The primary outcome of this study is to prevent tumor progression.

Clinical Trial Conditions for COPPER

Condition Name

Condition Name for COPPER
Intervention	Trials
Contraception	22
HIV	8
Wilson Disease	6
Glioblastoma Multiforme	4

Condition MeSH

Condition MeSH for COPPER
Intervention	Trials
Glioblastoma	7
Breast Neoplasms	7
Hepatolenticular Degeneration	7
Carcinoma	6

Clinical Trial Locations for COPPER

Trials by Country

Trials by Country for COPPER
Location	Trials
United States	205
Egypt	12
India	7
United Kingdom	7
Spain	4

Trials by US State

Trials by US State for COPPER
Location	Trials
California	17
New York	16
Michigan	16
Pennsylvania	15
Texas	12

Clinical Trial Progress for COPPER

Clinical Trial Phase

Clinical Trial Phase for COPPER
Clinical Trial Phase	Trials
Phase 4	23
Phase 3	14
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for COPPER
Clinical Trial Phase	Trials
Completed	82
Recruiting	26
Terminated	16

Clinical Trial Sponsors for COPPER

Sponsor Name

Sponsor Name for COPPER
Sponsor	Trials
National Cancer Institute (NCI)	8
Cairo University	7
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	7

Sponsor Type

Sponsor Type for COPPER
Sponsor	Trials
Other	223
Industry	38
NIH	34