Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00725751
First received: July 25, 2008
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

Although injection drug users represent the majority of new and existing cases of infection with hepatitis C virus (HCV), many lack access to treatment because of concerns about adherence, effectiveness, and reinfection. On the basis of a small but growing body of evidence showing that injection drug users can undergo treatment for HCV infection successfully, the 2002 NIH Consensus Statement on Hepatitis C has recommended that substance users be treated for HCV infection on a case-by-case basis. In this study, all patients will receive pegylated interferon alfa-2b (PegIFN-2b) and ribavirin according to European labeling; one cohort of participants will also be receiving substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine).


Condition Intervention
Hepatitis C, Chronic
Biological: Pegylated interferon alfa-2b (PegIFN-2b)
Drug: Ribavirin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Patients With/Without Substitution Therapy in Austria

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin [ Time Frame: 24 to 48 weeks ] [ Designated as safety issue: No ]
    For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.


Secondary Outcome Measures:
  • Number of Participants Who Achieved Sustained Virologic Response (SVR) [ Time Frame: 24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype) ] [ Designated as safety issue: No ]
    SVR was defined as a hepatitis C virus (HCV) ribonucleic acid (RNA) value below the limit of detection by polymerase chain reaction (PCR) analysis. For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.

  • Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy.


Enrollment: 353
Study Start Date: September 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PegIFN-2b/ribavirin with substitution therapy
Participants in this cohort received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
Biological: Pegylated interferon alfa-2b (PegIFN-2b)
PegIFN-2b administered according to European labeling.
Other Names:
  • PegIntron
  • SCH 54031
Drug: Ribavirin
Ribavirin administered according to European labeling.
Other Names:
  • Rebetol
  • SCH 18908
PegIFN-2b/ribavirin without substitution therapy
Participants in this cohort received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
Biological: Pegylated interferon alfa-2b (PegIFN-2b)
PegIFN-2b administered according to European labeling.
Other Names:
  • PegIntron
  • SCH 54031
Drug: Ribavirin
Ribavirin administered according to European labeling.
Other Names:
  • Rebetol
  • SCH 18908

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients receiving treatment for hepatitis C with/without substitution therapy at sites in Austria.

Criteria

Inclusion Criteria:

  • Adult patients with hepatitis C

Exclusion Criteria:

  • According to the products' European labeling
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00725751     History of Changes
Other Study ID Numbers: P05255
Study First Received: July 25, 2008
Results First Received: March 23, 2012
Last Updated: April 29, 2014
Health Authority: Austria: Not applicable

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

ClinicalTrials.gov processed this record on July 20, 2014