Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment

NCT01183169 | Completed Phase 2 Results DMC

• 2 other identifiers: CDEB025A22102010-020033-14
• Study Type: interventional
• Target: 459
• Locations: 14 countries
• Sites: 75

Brief Summary

The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.

Conditions

Hepatitis C

Keywords

Chronic hepatitis C; Cyclophilin inhibitor

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)

  cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (\< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.

  after 12 weeks of treatment

Secondary Outcomes (9)

• Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)

  after 12 weeks of treatment

• Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD

  12 weeks after treatment

• Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD

  24 weeks after treatment

• Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD

  after 4 weeks of treatment

• Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD

  after 12 weeks of treatment

Study Arms (5)

Treatment A: ALV 600 mg QD

EXPERIMENTAL

Alisporivir (ALV) 600 mg once daily (QD) with Peginterferon alfa-2a (PEG) and Ribavirin (RBV) for up to 48 weeks

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

Treatment B: ALV 800 mg QD

EXPERIMENTAL

Alisporivir (ALV) 800 mg QD with PEG and RBV for up to 48 weeks

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

Treatment C1: ALV Placebo - 600 mg QD

EXPERIMENTAL

ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV.

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

Treatment C2: ALV Placebo - 400 mg BID

EXPERIMENTAL

ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV.

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

Treatment D: ALV 400 mg BID

EXPERIMENTAL

Alisporivir (ALV) 400 mg twice daily BID with PEG and RBV for up to 48 weeks

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

Interventions

Alisporivir DRUG

ALV 200 mg soft gel capsules administered orally

Also known as: DEB025, ALV

Treatment A: ALV 600 mg QD; Treatment B: ALV 800 mg QD; Treatment C1: ALV Placebo - 600 mg QD; Treatment C2: ALV Placebo - 400 mg BID; Treatment D: ALV 400 mg BID

Peginterferon alfa-2a DRUG

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

Also known as: Pegasys®, PEG

Treatment A: ALV 600 mg QD; Treatment B: ALV 800 mg QD; Treatment C1: ALV Placebo - 600 mg QD; Treatment C2: ALV Placebo - 400 mg BID; Treatment D: ALV 400 mg BID

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®, RBV

Treatment A: ALV 600 mg QD; Treatment B: ALV 800 mg QD; Treatment C1: ALV Placebo - 600 mg QD; Treatment C2: ALV Placebo - 400 mg BID; Treatment D: ALV 400 mg BID

Placebo DRUG

ALV placebo soft gel capsules administered orally

Also known as: ALV Placebo

Treatment C1: ALV Placebo - 600 mg QD; Treatment C2: ALV Placebo - 400 mg BID

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 viral infection
• HCV RNA ≥ 1,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening
• Previous non-responders/relapsers to PEG and RBV after treatment for at least 12 weeks

You may not qualify if:

• Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening
• Women of child-bearing potential unless using highly effective
• Any other cause of relevant liver disease other than HCV

Sponsors & Collaborators

• Debiopharm International SA: lead

Study Sites (75)

Novartis Investigative Site

San Diego, California, 92101, United States

Location

Novartis Investigative Site

San Diego, California, 92115, United States

Location

Novartis Investigative Site

Ventura, California, 93003, United States

Location

Novartis Investigative Site

Bradenton, Florida, 34209, United States

Location

Novartis Investigative Site

Orlando, Florida, 32804, United States

Location

Novartis Investigative Site

Tampa, Florida, 33607, United States

Location

Novartis Investigative Site

Honolulu, Hawaii, 96814, United States

Location

Novartis Investigative Site

Honolulu, Hawaii, 96817, United States

Location

Novartis Investigative Site

Springfield, Illinois, 62703, United States

Location

Novartis Investigative Site

Topeka, Kansas, 66606, United States

Location

Novartis Investigative Site

Springfield, Massachusetts, 01107, United States

Location

Novartis Investigative Site

Egg Harbor Twp, New Jersey, 08234, United States

Location

Novartis Investigative Site

Brooklyn, New York, 11230, United States

Location

Novartis Investigative Site

New York, New York, 10021, United States

Location

Novartis Investigative Site

Arlington, Texas, 76012, United States

Location

Novartis Investigative Site

Dallas, Texas, 75246-2096, United States

Location

Novartis Investigative Site

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

San Antonio, Texas, 78215, United States

Location

Novartis Investigative Site

Kingswood, New South Wales, 2747, Australia

Location

Novartis Investigative Site

Kogarah, New South Wales, 2217, Australia

Location

Novartis Investigative Site

Westmead, New South Wales, 2145, Australia

Location

Novartis Investigative Site

Clayton, Victoria, 3168, Australia

Location

Novartis Investigative Site

Fitzroy, Victoria, 3065, Australia

Location

Novartis Investigative Site

Brussels, 1070, Belgium

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Nice, 06202, France

Location

Novartis Investigative Site

Paris, 75006, France

Location

Novartis Investigative Site

Berlin, 10969, Germany

Location

Novartis Investigative Site

Cologne, 50937, Germany

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

Location

Novartis Investigative Site

Hamburg, 20099, Germany

Location

Novartis Investigative Site

Leipzig, 04103, Germany

Location

Novartis Investigative Site

Békéscsaba, H-5600, Hungary

Location

Novartis Investigative Site

Budapest, 1083, Hungary

Location

Novartis Investigative Site

Budapest, 1126, Hungary

Location

Novartis Investigative Site

Debrecen, 4032, Hungary

Location

Novartis Investigative Site

Kaposvár, 7400, Hungary

Location

Novartis Investigative Site

Székesfehérvár, 8000, Hungary

Location

Novartis Investigative Site

Antella - Bagno A Ripoli, FI, 50012, Italy

Location

Novartis Investigative Site

Palermo, PA, 90127, Italy

Location

Novartis Investigative Site

Padua, PD, 35128, Italy

Location

Novartis Investigative Site

Parma, PR, 43100, Italy

Location

Novartis Investigative Site

Roma, RM, 00161, Italy

Location

Novartis Investigative Site

Bologna, 40138, Italy

Location

Novartis Investigative Site

Bialystok, 15-540, Poland

Location

Novartis Investigative Site

Lódz, 91-347, Poland

Location

Novartis Investigative Site

Warsaw, 01-201, Poland

Location

Novartis Investigative Site

San Juan, 00909, Puerto Rico

Location

Novartis Investigative Site

Bucharest, District 1, 050526, Romania

Location

Novartis Investigative Site

Bucharest, District 3, 030317, Romania

Location

Novartis Investigative Site

Iași, Iaşi, 700506, Romania

Location

Novartis Investigative Site

Bucharest, Romania, 021105, Romania

Location

Novartis Investigative Site

Bucharest, 020125, Romania

Location

Novartis Investigative Site

Seville, Andalusia, 41014, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

Madrid, Madrid, 28029, Spain

Location

Novartis Investigative Site

Majadahonda, Madrid, 28222, Spain

Location

Novartis Investigative Site

Niaosong Township, Taiwan, 83301, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan, 10002, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan, ROC, 112, Taiwan

Location

Novartis Investigative Site

Douliu, 640, Taiwan

Location

Novartis Investigative Site

Kaohsiung City, 807, Taiwan

Location

Novartis Investigative Site

Keelung, 20401, Taiwan

Location

Novartis Investigative Site

Lin-Ko, 33305, Taiwan

Location

Novartis Investigative Site

Ankara, Turkey, 06100, Turkey (Türkiye)

Location

Novartis Investigative Site

Ankara, Turkey, 06800, Turkey (Türkiye)

Location

Novartis Investigative Site

Izmir, Turkey, 35040, Turkey (Türkiye)

Location

Novartis Investigative Site

Fatih / Istanbul, 34098, Turkey (Türkiye)

Location

Novartis Investigative Site

London, E1 1BB, United Kingdom

Location

Novartis Investigative Site

London, NW3 2PR, United Kingdom

Location

Novartis Investigative Site

London, W2 1NY, United Kingdom

Location

Novartis Investigative Site

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

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; 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

In April 2012, ALV and placebo were discontinued in all participants. Participants remained on PEG and RBV treatment.

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 Pharmaceuticals

  Novartis Pharmaceuticals

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2010
• First Posted: August 17, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 25, 2016
• Results First Posted: August 25, 2016

Record last verified: 2016-07

Locations

FR (2); PR (1); DE (6); IT (6); ES (6); RO (5); AU (5); TW (7); TU (4); GB (4); BE (2); US (18); PL (3); HU (6)