Real-life Surveillance Study of Patients With Chronic Hepatitis C Treated With PegIntron Injector and Rebetol (Study P04538)(COMPLETED)

NCT00727311 | Completed Results

• 1 other identifier: P04538
• Study Type: observational
• Target: 2,302
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the study is to assess the safety and efficacy of PegIntron injector and Rebetol administered to participants with chronic hepatitis C. Participants will be treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study will assess the rates of eradication of the hepatits C virus and the rates of serious adverse events reported with PegIntron (1.5 μg/kg/week) and Rebetol (800-1200 mg/day) in common medical practice in Germany.

Conditions

Hepatitis C, Chronic; Hepatitis C

Outcome Measures

Primary Outcomes (4)

• Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT)

  HCV-RNA level was measured by polymerase chain reaction (PCR).

  24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6

• Number of Participants With Early Virologic Response (EVR)

  EVR was defined as at least a 2 log reduction in HCV-RNA or HCV-RNA negativity from baseline to Week 12

  Treatment Week 12

• Number of Participants With Sustained Virologic Response (SVR)

  SVR was defined as HCV-RNA negativity at EoT and at the follow-up 6 months after the EoT

  24 weeks post-treatment (Week 48 or 72, depending on genotype)

• Number of HCV-RNA Negative Participants at Follow-up

  HCV-RNA was measured by PCR.

  24 weeks post-treatment (Weeks 48 or 72, depending on genotype)

Study Arms (1)

PegIntron + Rebetol

Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy

Biological: PegIntron (peginterferon alfa-2b; SCH 54031) injector; Drug: Rebetol (ribavirin; SCH 18908)

Interventions

PegIntron (peginterferon alfa-2b; SCH 54031) injector BIOLOGICAL

PegIntron administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling

Also known as: SCH 54031

PegIntron + Rebetol

Rebetol (ribavirin; SCH 18908) DRUG

Rebetol administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling

Also known as: SCH 18908

PegIntron + Rebetol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with chronic hepatitis C, who are either treatment-naïve or previous relapsers after interferon monotherapy, from 500 sites in Germany

You may qualify if:

• Participants with chronic hepatitis C
• At least 18 years old
• Treatment-naïve or relapse to interferon monotherapy
• Platelets \>= 100,000/mm\^3
• Neutrophil counts \>= 1,500/ mm\^3
• Thyroid Stimulating Hormone (TSH) must be within normal limits
• Hemoglobin \>= 12 gr/dl (females); \>= 13 gr/dl (males)
• Intravenous drug abusers (Ex-IVDA) participants being under stable substitution for at least 6 months
• Women of childbearing potential must have a routine pregnancy test performed monthly during treatment and for 7 months thereafter. Sexually active female participants of childbearing potential must be practicing adequate contraception (intrauterine device, oral contraceptives, implanted contraceptives, surgical sterilization, barrier method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom (+ spermicide) during the treatment period and for 7 months after stopping treatment
• Sexually active male participants must be practicing acceptable methods of contraception (vasectomy, use of condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 7 months after stopping treatment

You may not qualify if:

• Contraindications as per the SPC and approved European labeling
• Hypersensitivity to the active substance or to any inteferons or to any of the excipients
• Pregnant woman
• Woman who are breast-feeding
• Existence of or history of severe psychiatric condition, in particular severe depression, suicidal ideation or suicide attempt
• A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
• Severe debilitating medical conditions, including participants with chronic renal failure or creatinine clearance \< 50 mL/min
• Autoimmune hepatitis or history of autoimmune disease
• Severe hepatic dysfunction or decompensated cirrhosis of the liver
• Pre-existing thyroid disease unless it can be controlled with conventional therapy
• Epilepsy and/or compromised central nervous system function

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; 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: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclsoure@merck.com

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2008
• First Posted: August 1, 2008
• Study Start: August 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 9, 2015
• Results First Posted: January 10, 2011

Record last verified: 2015-10