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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01446250
First received: September 26, 2011
Last updated: October 12, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Liver Disease
Drug: DEB025 plus peg-IFN alpha 2a and ribavirin fixed duration treatment
Drug: DEB025 plus peg-IFN alpha 2a and ribavirin response guided treatment duration
Drug: Boceprevir plus peg-IFN alpha 2a and ribavirin per label response guided treatment
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Proportion of patients that discontinue study drug or require dose reduction or dose interruption due to treatment-emergent Adverse Events. [ Time Frame: Participants will be followed for the duration of treatment, an expected average of 48 weeks ] [ Designated as safety issue: Yes ]
    The proportion of patients that discontinue study drug or require dose reduction or dose interruption during treatment due to treatment-emergent Adverse Events.


Secondary Outcome Measures:
  • Proportion of patients with emergence of resistant mutations in each treatment arm. [ Time Frame: Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 while patient is on treatment. ] [ Designated as safety issue: Yes ]
    The proportion of patients that develop resistant mutations in each treatment arm, measured by hepatitis C viral load sequencing analysis.

  • 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. [ Time Frame: 24 weeks after treatment completion. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 210
Study Start Date: December 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
Eligible participants receive Peg-IFN once weekly injection plus oral Ribavirin BID plus oral DEB025 400mg BID for 48 weeks.
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.
Experimental: Treatment B

Eligible participants receive response-guided treatment with Peg-IFN injection once weekly plus oral Ribavirin BID plus oral DEB025 400mg BID for 24 or 48 weeks based on week 4 and week 12 HCV RNA results.

DEB025/ peg-IFN alpha 2a/RBV response-guided treatment duration:

  • Patients with a viral load below the level of quantification (LOQ) at week 4 and below the level of detection (LOD) at week 12 will stop peg-IFN alpha 2a/RBV and DEB025 study medications after 24 weeks.
  • Patients with a viral load at or above the level of quantification (LOQ) at week 4 or above the level of detection (LOD) at week 12 will complete 48 weeks of peg-IFN alpha 2a/RBV and DEB025 study treatment
Drug: 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.
Active Comparator: Treatment C

Eligible participants receive per boceprevir(BOC) label response-guided treatment of Peg-IFNalpha2a(Peg-IFN) injection once weekly plus oral Ribavirin(RBV) BID for 4 wks followed by Peg-IFN injection once weekly plus oral RBV BID plus oral BOC 800mg TID for 24, 32 or 44 wks based on week 8 and week 24 HCV RNA results and compensated cirrhosis diagnosis.

Response-guided treatment: Pts with viral load (VL) below level of detection (LOD) at wk8 and VL below LOD at wk24 will stop peg-IFN,RBV and BOC at wk 28.

Pts with VL above LOD at wk 8 and VL below LOD at wk24 will stop BOC at wk 36 and will stop peg-IFN,RBV at wk48. Pts with compensated cirrhosis will stop peg-IFN,RBV and BOC at wk48.

Pts with serum HCV RNA concentration >= 100 IU/mL at wk12, confirmed VL above LOD at wk24, incomplete viral response with rebound or confirmed viral breakthrough at any time will be offered treatment with DEB025,peg-IFN,RBV for 48 wks plus 24 wks treatment-free followup.

Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446250

Locations
United States, California
Novartis Investigational Site
Beverly Hills, California, United States, 90211
United States, Maryland
Novartis Investigational Site
Baltimore, Maryland, United States, 21229
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01446250     History of Changes
Other Study ID Numbers: CDEB025A2307
Study First Received: September 26, 2011
Last Updated: October 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Hepatitis C
chronic
African American
controlled clinical trials
randomized
peginterferon alpha-2a
ribavirin,boceprevir
cyclophilin inhibitor
genotype 1
HCV
viral infection

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Liver Diseases
Hepatitis C, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferons
Ribavirin
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites

ClinicalTrials.gov processed this record on April 16, 2014