Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1

NCT01446250 | Terminated Phase 3 Results

• 1 other identifier: CDEB025A2307
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC), each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African American participants who have never received treatment for their chronic hepatitis C (HCV) genotype 1 infection.

Conditions

Hepatitis C

Keywords

Chronic hepatitis C; Cyclophilin inhibitor

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events

  within 48 weeks

Secondary Outcomes (2)

• Percentage of Participants With Emergence of Resistant Mutations

  within 48 weeks

• Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 24 Weeks After the End of Treatment (SVR24)

  24 weeks post-treatment

Study Arms (2)

Alisporivir

EXPERIMENTAL

At the time of partial clinical hold, participants randomized to original treatment arms A and B (Alisporivir triple therapy arms with Peginterferon alfa-2a and Ribavirin) discontinued alisporivir treatment immediately while continuing their treatments with the other two therapies. These participants were combined into the same arm because they received the same dose of alisporivir 400 mg twice per day (BID) for the same duration. Amendment 1 offered them the opportunity to continue in the study receiving boceprevir triple therapy.

Drug: Alisporivir; Drug: Peginterferon alfa-2a; Drug: Ribavirin

Boceprevir

ACTIVE COMPARATOR

Participants randomized to boceprevir triple therapy with Peginterferon alfa-2a and Ribavirin (the original treatment arm C).

Drug: Boceprevir; Drug: Peginterferon alfa-2a; Drug: Ribavirin

Interventions

Alisporivir DRUG

ALV 200 mg soft gel capsules administered orally

Also known as: DEB025

Alisporivir

Boceprevir DRUG

BOC 800 mg (4 x 200 mg soft gel capsules) administered orally

Also known as: Victrelis®

Boceprevir

Peginterferon alfa-2a DRUG

PEG 180 μg administered via subcutaneous (s.c.) injection once weekly

Also known as: Pegasys®

Alisporivir; Boceprevir

Ribavirin DRUG

RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose

Also known as: Copegus®

Alisporivir; Boceprevir

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic HCV genotype 1 infection
• No previous treatment for HCV 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

You may not qualify if:

• 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
• Alanine aminotransferase (ALT) ≥ 10 times ULN, more than 1 episode of elevated bilirubin (\> ULN) in past 6 months

Sponsors & Collaborators

• Debiopharm International SA: lead

Study Sites (2)

Novartis Investigational Site

Beverly Hills, California, 90211, United States

Location

Novartis Investigational Site

Baltimore, Maryland, 21229, United States

Location

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

Interventions

alisporivir; N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

Due to the early termination of study enrollment and discontinuation of alisporivir treatment, Amendment 1 changed the number of study arms to 2, combining Arms A and B, and none of the planned outcome measures could be evaluated.

Results Point of Contact

• Title: Vice President Clinical Research & Development
• Organization: Debiopharm International S.A.

info-international@debiopharm.com

4121 321 01 11

Study Officials

• Novartis Pharmaceticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: October 5, 2011
• Study Start: December 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 16, 2017
• Results First Posted: January 16, 2017

Record last verified: 2016-11

Locations

US (2)