Miravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C

NCT ID: NCT01727934

Last Updated: 2014-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-04-30

Brief Summary

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.

Conditions

Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Miravirsen sodium

Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg then 4 every other week doses at 5 mg/kg.

Group Type: EXPERIMENTAL

Miravirsen sodium

Intervention Type: DRUG

Subcutaneous injection

Interventions

Miravirsen sodium

Subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

SPC3649

Eligibility Criteria

Inclusion Criteria

• Diagnosis of chronic hepatitis C
• HCV genotype 1
• BMI 18-38 kg/m2
• Null responder to pegylated interferon alpha and ribavirin

Exclusion Criteria

• Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Significant liver disease in addition to hepatitis C
• Decompensated liver disease medical history or current clinical features
• Histologic evidence of hepatic cirrhosis
• Concurrent clinically significant medical diagnosis (other than CHC)
• Concurrent social conditions (e.g. drugs of abuse, alcohol excess, poor living accommodation)
• Clinically significant illness within 30 days preceding entry into the study
• Participated in an investigational drug study within 30 days or 5 half-lives, whichever is longer, prior to the start of study medication
• History of clinically significant allergic drug reactions

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Santaris Pharma A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maribel Rodriguez-Torres, MD

Role: PRINCIPAL_INVESTIGATOR

Fundacion de Investgacion de Diego

Locations

Fundacion de Investigation de Diego

San Juan, , Puerto Rico

Countries

Puerto Rico

Other Identifiers

SPC3649-207

Identifier Type: -

Identifier Source: org_study_id