Study of DEB025/Alisporivir Plus Pegylated Interferon alfa2a and Ribavirin and Boceprevir Plus Pegylated Interferon alfa2a and Ribavirin in African American Chronic Hepatitis C Genotype 1 Patients That Have Never Received Treatment for Their Hepatitis C

Hepatitis C Clinical Trial

Official title:

A Randomized, Open Label Trial of the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-INFα2a/RBV) and Boceprevir in Combination With Peg-INFα2a/RBV in African American Treatment-naϊve Patients With Chronic Hepatitis C Genotype 1

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01446250
• Other study ID #: CDEB025A2307
• Status: Terminated
• Phase: Phase 3
• First received: September 26, 2011
• Last updated: April 1, 2016
• Start date: December 2011
• Est. completion date: May 2013

Study information

• Verified date: April 2016
• Source: Debiopharm International SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety and efficacy of alisporivir plus pegylated interferon alfa2a and Ribavirin as well as boceprevir plus pegylated interferon alfa2a and Ribavirin in African American chronic hepatitis C genotype 1 patients that have never received treatment for their hepatitis C.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

• Chronic hepatitis C virus infection.

• Infection with HCV genotype 1

• No previous treatment for Hepatitis C virus infection

• African American ethnicity.

• Serum HCV RNA = 1000 IU/ml, assessed by quantitative polymerase chain reaction or equivalent at screening visit, no upper limit.

• A liver biopsy within 3 years prior to baseline.

Exclusion criteria:

• HCV genotype different from genotype 1 or co-infection with other HCV genotype

• Co-infection with Hepatitis B or HIV

• Any other cause of relevant liver disease other than HCV

• Presence or history of hepatic decompensation

• ALT = 10 times ULN, more than 1 episode of elevated bilirubin (>ULN) in past 6 months Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Liver Disease
• Liver Diseases

Intervention

Drug:
• DEB025 plus peg-IFN alpha 2a and ribavirin fixed duration treatment
Patients will receive Peg-IFN once weekly injection plus Ribavirin BID plus DEB025 400mg BID for 48 weeks.
• DEB025 plus peg-IFN alpha 2a and ribavirin response guided treatment duration
Patients will receive Peg-IFN once weekly injection plus Ribavirin BID plus DEB025 400mg BID for either 24 or 48 weeks.
• Boceprevir plus peg-IFN alpha 2a and ribavirin per label response guided treatment
Patients will receive Peg-IFN once weekly injection plus Ribavirin BID for 4 weeks followed by Peg-IFN once weekly injection plus Ribavirin BID plus boceprevir 800 mg TID for 24, 32 or 44 weeks per boceprevir label.

Locations

Country	Name	City	State
United States	Novartis Investigational Site	Baltimore	Maryland
United States	Novartis Investigational Site	Beverly Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Debiopharm International SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients that discontinue study drug or require dose reduction or dose interruption due to treatment-emergent Adverse Events.	The proportion of patients that discontinue study drug or require dose reduction or dose interruption during treatment due to treatment-emergent Adverse Events.	Participants will be followed for the duration of treatment, an expected average of 48 weeks	Yes
Secondary	Proportion of patients with emergence of resistant mutations in each treatment arm.	The proportion of patients that develop resistant mutations in each treatment arm, measured by hepatitis C viral load sequencing analysis.	Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 while patient is on treatment.	Yes
Secondary	Proportion of patients that achieve Sustained Viral Response Week 24 (SVR24) defined as serum HCV RNA undetectable by limit of detection (LOD) 24 weeks after end of treatment.	Proportion of patients that achieve Sustained Viral Response Week 24 (SVR24) defined as serum HCV RNA undetectable by limit of detection (LOD) 24 weeks after end of treatment, measured by hepatitis C RNA in serum. The COBAS TaqMan HCV test (v2.0) will be used to assessment of HCV viral load.	24 weeks after treatment completion.	No