Safety and Efficacy of PegIntron Plus Rebetol in Patients With Chronic Hepatitis C in Japan, Excluding (1) Subjects With HCV Genotype 1 and High Viral Load, and (2) Interferon-naïve Subjects With Low Viral Load (Study P04841)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00724230
First received: July 25, 2008
Last updated: February 15, 2013
Last verified: February 2013
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Purpose
The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol combination therapy administered to patients with chronic hepatitis C. The study will exclude (1) subjects with HCV genotype 1 and high viral load, and (2) interferon-naïve subjects with low viral load. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
| Condition | Intervention |
|---|---|
|
Hepatitis C, Chronic Hepatitis C |
Drug: PegIntron (peginterferon alfa-2b; SCH 54031) Drug: Rebetol (ribavirin; SCH 18908) |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | PegIntron/REBETOL Combination Therapy Designated Drug Use Investigation -Investigation on the Safety and Efficacy of PegIntron and REBETOL Combination Therapy in Patients With Chronic Hepatitis C Excluding Those With "IFN Naive Low Viral Load and Genotype 1 and High Viral Load"- |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Overall incidence of adverse events and adverse drug reactions. [ Time Frame: Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study ] [ Designated as safety issue: Yes ]
- Assessment of trends of adverse drug reactions by patient factors and concomitant medications; Incidence, severity, and outcome of adverse events (AEs) between the elderly vs younger patients [ Time Frame: Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study ] [ Designated as safety issue: Yes ]
- Sustained virologic response rate by HCV genotype, baseline viral load, and patient demographic characteristics [ Time Frame: Assessed at 24 weeks post-treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Rate of ALT normalization at end of treatment period and at 24 weeks post completing therapy. [ Time Frame: End of treatment and 24 weeks after end of treatment ] [ Designated as safety issue: No ]
| Enrollment: | 505 |
| Study Start Date: | February 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Arm 1
Overall study population.
|
Drug: PegIntron (peginterferon alfa-2b; SCH 54031)
PegIntron administered in accordance with approved labeling Subcutaneous injection once weekly for 24 weeks.
Other Name: SCH 54031
Drug: Rebetol (ribavirin; SCH 18908)
Rebetol administered orally twice daily in accordance with approved labeling. Dosing duration 24 weeks.
Other Name: SCH 18908
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with chronic hepatitis C excluding subjects with HCV genotype 1 and high viral load, and interferon-naïve subjects with low viral load. Patients undergoing treatment with PegIntron and Rebetol in clinical practice at approximately 50 to 100 sites in Japan.
Criteria
Inclusion Criteria:
- Patients diagnosed with chronic hepatitis C
- Among interferon-naïve patients, only patients with high viral load and HCV genotype other than 1
- Among prior nonresponders or relapsers to interferon monotherapy, (1) patients with high viral load and HCV genotype other than 1; and (2) patients with low viral load of all genotypes (including genotype 1)
Exclusion Criteria:
- Patients infected with HCV genotype 1 with high viral load, regardless of whether treatment-naïve or previous nonresponders/relapsers
- Interferon-naïve patients with low viral load
- Patients with a history of hypersensitivity to test drugs or other interferon preparations
- Patients with a history of hypersensitivity to biological products, such as vaccines
- Patients being treated with Shosaikoto
- Patients with autoimmune hepatitis
- Pregnant women, women who may be pregnant, and nursing mothers
- Patients with a history of hypersensitivity to any component of this drug or other nucleoside analogs (aciclovir, ganciclovir, vidarabine, etc.)
- Patients with difficult-to-control cardiac disease (eg, myocardial infarction, cardiac failure, arrhythmia)
- Patients with hemoglobinopathies (eg, thalassemia, sickle-cell anemia)
- Patients with chronic renal failure or renal function disorder with creatinine clearance of <=50 mL/min
- Patients with or a history of severe psychiatric condition such as severe depression, suicidal ideation or suicide attempt
- Patients with serious hepatic dysfunction
- Patients with autoimmune hepatitis
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00724230 History of Changes |
| Other Study ID Numbers: | P04841 |
| Study First Received: | July 25, 2008 |
| Last Updated: | February 15, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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 Ribavirin Peginterferon alfa-2b Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013