Evaluating Safety and Efficacy In Hepatitis C Patients After PegIntron Pen Treatment (Study P04896)

NCT01340573 | Terminated Results

• 1 other identifier: P04896
• Study Type: observational
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a non-interventional study designed to evaluate the efficacy and safety of combination study drugs in the treatment of participants diagnosed with Chronic Hepatitis C (CHC). CHC participants with confirmed positive hepatitis-C virus (HCV) RNA in plasma, and who have not been previously treated with the Pegylated interferon (PegIntron) Pen, were enrolled into study.

Conditions

Chronic Hepatitis C

Keywords

Chronic Hepatitis C; pegylated interferon; PegIntron Pen; Ribavirin

Outcome Measures

Primary Outcomes (4)

• Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-48 of Study Treatment

  Collection of all safety reports (serious adverse events) from genotype-1 population at week-48 of treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.

  Week-48

• Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 Follow-up

  Collection of all safety reports (serious adverse events) from genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.

  Week-24 follow-up

• Number of Non-genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 of Study Treatment

  Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 of study treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.

  Week-24

• Number of Non-genotype 1 Participants Who Experienced Serious Adverse Events (SAE) on Week-24 Follow-up

  Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.

  Week-24 follow-up

Secondary Outcomes (5)

• Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 of Study Treatment

  Week-24

• Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up

  Week-24 follow-up

• Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-48 of Study Treatment

  Week-48

• Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up

  Week-24 follow-up

• Participants' Overall Rating of Satisfaction and the Use of Training Materials for the Pegintron Pen, as Provided in a Study Questionnaire

  Week 12

Study Arms (2)

Genotype 1 CHC Participants

Drug: PegIntron Pen; Drug: Ribavirin

Non-genotype 1 CHC participants

Drug: PegIntron Pen; Drug: Ribavirin

Interventions

PegIntron Pen DRUG

Peginterferon alfa-2b, 1.5 microgram/kg each week, administered subcutaneously.

Also known as: pegylated interferon Pen

Genotype 1 CHC Participants; Non-genotype 1 CHC participants

Ribavirin DRUG

Dose is based on body weight. Each tablet of ribavirin is 200mg, and given by oral administration. Participants with body weight of \<65 kg were administered 800 mg of ribavirin daily, body weight of 65 kg-85 kg received 1000 mg daily, and participants with a body weight of \>85 kg received 1200 mg of ribavirin daily.

Also known as: Ribasphere, Vilona, Copegus, Rebetol, Virazole

Genotype 1 CHC Participants; Non-genotype 1 CHC participants

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

Indonesian participants ≥18 years of age with confirmed chronic hepatitis C with HCV RNA positive in plasma.

You may qualify if:

• Demonstrate willingness to participate in the study and comply with its procedures by signing a written informed consent.
• Equal to or greater than 18 years.
• Confirmed chronic hepatitis C with hepatitis C virus (HCV) RNA positive in plasma.
• No previous use of PegIntron Pen.

You may not qualify if:

• Hypersensitivity to the active substance or to any interferon or to any of the excipients.
• Pregnant women.
• Women who are breastfeeding.
• Existence of or a history of severe psychiatric condition, particularly 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 condition, including patients with chronic renal failure or creatinine clearance \< 50 ml/minute.
• Auto immune hepatitis or a history of autoimmune disease.
• Severe hepatic dysfunction or decompensated cirrhosis of the liver.
• Pre-existing thyroid disease unless it can be controlled with conventional treatment.
• Epilepsy and/or compromised central nervous system (CNS) function.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Biospecimen

Retention: SAMPLES WITH DNA

Efficacy measurements for sustained viral response HCV RNA were collected at week 24 of study treatment and at week 24 of follow-up in Non-genotype-1 participants. Efficacy measurements for Genotype-1 participants for sustained viral response HCV RNA were collected at week 24 and at week 48 of study treatment, and at week 24 of follow-up.

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; 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.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: April 22, 2011
• Study Start: March 23, 2007
• Primary Completion: October 29, 2007
• Study Completion: October 29, 2007
• Last Updated: June 12, 2024
• Results First Posted: January 30, 2012

Record last verified: 2024-05