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

Hepatitis C Clinical Trial

Official title:

A Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C (CHC) Virus Genotype 1 Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01727934
• Other study ID #: SPC3649-207
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 12, 2012
• Last updated: January 3, 2014
• Start date: November 2012
• Est. completion date: April 2014

Study information

• Verified date: January 2014
• Source: Santaris Pharma A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Miravirsen sodium
Subcutaneous injection

Locations

Country	Name	City	State
Puerto Rico	Fundacion de Investigation de Diego	San Juan

Sponsors (1)

Lead Sponsor	Collaborator
Santaris Pharma A/S

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Viral resistance analysis at baseline and throughout the study.	The miR-122 seed sites in HCV RNA from subjects at baseline and following viral breakthrough or relapse will be subjected to genotypic sequence analysis.	60 weeks	No
Other	Plasma pharmacokinetics	Plasma PK for miravirsen levels will be determined for up to 2 hours post-dose on Day 1, up to 24 hours post-dose on Days 29 and 84, and pre-dose for all other treatment period visits. Additionally, plasma PK will be evaluated at all follow-up visits through Week 28.	28 weeks	No
Other	Urine pharmacokinetics		Up to 24 hours post-dose on Day 29 and Day 84	No
Primary	The proportion of subjects with sustained virological response 24 weeks after the end of therapy.		36 weeks	No
Secondary	The proportion of subjects with a sustained virological response 12 and 48 weeks after the end of therapy.		60 weeks	No
Secondary	The proportion of subjects with undetectable HCV RNA levels at the end of treatment.		12 weeks	No
Secondary	Change in HCV RNA levels from baseline throughout the study.		60 weeks	No
Secondary	The proportion of subjects who experience virological failure throughout the study.		60 weeks	No
Secondary	Safety will be assessed by evaluation of adverse events, physical examinations, vital signs, 12-lead ECGs, and laboratory assessments (clinical chemistry, hematology, urinalysis).		60 weeks	Yes