CLINICAL TRIALS PROFILE FOR MIRAVIRSEN

Clinical Trials for Miravirsen

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01200420 ↗	Multiple Ascending Dose Study of Miravirsen in Treatment-Naïve Chronic Hepatitis C Subjects	Completed	Santaris Pharma A/S	Phase 2	The main purpose of this study is to determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with chronic hepatitis C. Secondary purpose includes assessment of pharmacokinetics of miravirsen and assessment of miravirsen's effect on HCV viral titer.
NCT01646489 ↗	Drug Interaction Study to Assess the Effect of Co-Administered Miravirsen and Telaprevir in Healthy Subjects	Completed	Santaris Pharma A/S	Phase 1	The purpose of this study is to assess the safety, tolerability, and affect on blood levels of miravirsen and telaprevir when administered together.
NCT01727934 ↗	Miravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C	Unknown status	Santaris Pharma A/S	Phase 2	The purpose of this open-label study is to assess the safety, antiviral activity, and pharmacokinetics of 9 subcutaneous injections of miravirsen monotherapy (5 weekly doses over 5 weeks, followed by a further 4 doses once every other week over 7 weeks) over a total of 12 weeks of treatment. The subjects enrolled in this study are chronically infected with HCV genotype 1 and are null responders to treatment with peg IFNα/RBV therapy.
NCT01872936 ↗	Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection	Unknown status	Santaris Pharma A/S	Phase 2	The purpose of this open-label study is to assess the safety, tolerability, antiviral activity, genotype resistance associated with virological failure, pharmacokinetics and pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and ribavirin in subjects with hepatitis C virus genotype 1 infection who are null responder to pegylated-interferon alpha and ribavirin.
NCT02031133 ↗	Long-term Extension to Miravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C	Active, not recruiting	Santaris Pharma A/S	Phase 2	Study SPC3649-207E is designed as an extension study to the prior protocol to provide additional long-term safety and efficacy information for subjects participating in Study SPC3649-207.

Clinical Trial Conditions for Miravirsen

Condition Name

Condition Name
Intervention	Trials
Hepatitis C	4
Hepatitis C, Chronic	1
Chronic Hepatitis C	1

Condition MeSH

Condition MeSH
Intervention	Trials
Hepatitis C, Chronic	5
Hepatitis C	5
Hepatitis A	5
Hepatitis	5

Clinical Trial Locations for Miravirsen

Trials by Country

Trials by Country
Location	Trials
Puerto Rico	4
United States	3
Netherlands	1
Slovakia	1
Germany	1

Trials by US State

Trials by US State
Location	Trials
Texas	2
Wisconsin	1

Clinical Trial Progress for Miravirsen

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 2	4
Phase 1	1

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	2
Unknown status	2
Active, not recruiting	1

Clinical Trial Sponsors for Miravirsen

Sponsor Name

Sponsor Name
Sponsor	Trials
Santaris Pharma A/S	5

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	5