A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment

NCT00537407 | Completed Phase 2 Results DMC

• 2 other identifiers: Debio 025-HCV-207DEB025A2207
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

Brief Summary

Debio 025 (alisporivir) is an oral cyclophilin inhibitor with a new mechanism of action demonstrating potent anti-hepatitis C virus (HCV) activity in pre-clinical models and patients. The current standard of care (SOC) in HCV patients consists of a combination of peg-IFN alpha and ribavirin. Treatment duration and ribavirin dose depend on the genotype treated. Only 40-50% of patients with genotype 1 achieve a sustained viral response (SVR). This study assesses whether Debio 025 administered in combination with peg-IFN alpha 2a and ribavirin can improve the outcome of treatment in this group of patients.

Conditions

Chronic Hepatitis C

Keywords

Hepatitis; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Triple Therapy Treatment Arms (A, D, and E)

  Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.

  Baseline to Day 29

Secondary Outcomes (6)

• Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Monotherapy and Dual Therapy Treatment Arms (B and C)

  Baseline to Day 29

• log10 Hepatitis C Virus RNA at Day 29

  Day 29

• Percentage of Participants With a Rapid Viral Response at Day 29

  Day 29

• Percentage of Participants With an Early Viral Response at Week 12

  Baseline to Week 12

• Percentage of Participants With an End-of-treatment Response at the End of Treatment (Week 48 or 72)

  End of treatment (Week 48 or 72)

Study Arms (5)

Treatment Arm A

EXPERIMENTAL

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Drug: Debio 025; Drug: Peg-IFNα2a; Drug: Ribavirin

Treatment Arm B

EXPERIMENTAL

Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Drug: Debio 025; Drug: Peg-IFNα2a; Drug: Ribavirin

Treatment Arm C

EXPERIMENTAL

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Drug: Debio 025; Drug: Peg-IFNα2a; Drug: Ribavirin

Treatment Arm D

EXPERIMENTAL

Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Drug: Debio 025; Drug: Peg-IFNα2a; Drug: Ribavirin

Treatment Arm E

EXPERIMENTAL

Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Drug: Debio 025; Drug: Peg-IFNα2a; Drug: Ribavirin

Interventions

Debio 025 DRUG

Debio 025 supplied as a 100 mg/mL oral solution

Also known as: Alisporivir

Treatment Arm A; Treatment Arm B; Treatment Arm C; Treatment Arm D; Treatment Arm E

Peg-IFNα2a DRUG

Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Also known as: PEGASYS

Treatment Arm A; Treatment Arm B; Treatment Arm C; Treatment Arm D; Treatment Arm E

Ribavirin DRUG

Ribavirin supplied as 200 mg tablets

Also known as: Copegus

Treatment Arm A; Treatment Arm B; Treatment Arm C; Treatment Arm D; Treatment Arm E

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients between 18 and 60 years of age.
• Hepatitis B negative and human immunodeficiency virus (HIV) negative.
• Diagnosed with hepatitis C genotype I and not responsive to treatments such as peginterferon alpha-2a or 2b and ribavirin for at least 12 weeks.
• Adequate liver function (Child-Pugh-Turcotte score A) and other laboratory parameters within acceptable range.
• Females may participate only if they cannot become pregnant, i.e., are surgically sterile, post-menopausal, or using 2 reliable contraceptive methods.
• Male patients must be surgically sterile or utilizing a barrier contraceptive method.
• For female patients of child bearing potential, negative pregnancy test within 1 week of first investigational product administration.

You may not qualify if:

• Treatment with any investigational drug within 6 months prior to the start of the study.
• Ongoing or recent use of antiviral medication within 1 month before the start of the study.
• A known bad reaction or intolerance to Debio 025, peginterferon alpha-2a, and/or ribavirin.
• Presence or history of any severe related disease.

Sponsors & Collaborators

• Debiopharm International SA: lead

Study Sites (7)

Scripps Clinic Liver Disease Research Center

La Jolla, California, 92037, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

University of Miami Center for Liver Diseases

Miami, Florida, 33136, United States

Location

The Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

Methodist Transplant Physicians

Dallas, Texas, 75203, United States

Location

Metropolitan Research

Fairfax, Virginia, 22031, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis; Hepatitis C

Interventions

alisporivir; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Jean-Maurice Dumont, Vice President Medical Affairs
• Organization: Debiopharm International S.A.

jean-maurice.dumont@debiopharm.com

4121 321 01 11

Study Officials

• Raf Crabbé, MD

  Debiopharm International S.A.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2007
• First Posted: October 1, 2007
• Study Start: September 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 17, 2016
• Results First Posted: May 7, 2015

Record last verified: 2016-02

Locations

US (7)