---
title: Patient Compliance During PegIntron and Rebetol Combination Therapy in Chronic Hepatitis C (Study P04690)
nct_id: NCT00725205
overall_status: COMPLETED
sponsor: Merck Sharp & Dohme LLC
study_type: OBSERVATIONAL
primary_condition: Hepatitis C, Chronic
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00725205.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00725205"
ct_last_update_post_date: 2015-10-08
last_seen_at: "2026-05-12T06:22:01.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Patient Compliance During PegIntron and Rebetol Combination Therapy in Chronic Hepatitis C (Study P04690)

**Official Title:** Patient Compliance During PegIntron (Injection Pen) and Rebetol Combination Therapy in Chronic Hepatitis C

**NCT ID:** [NCT00725205](https://clinicaltrials.gov/study/NCT00725205)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 294
- **Lead Sponsor:** Merck Sharp & Dohme LLC
- **Conditions:** Hepatitis C, Chronic, Hepatitis C
- **Start Date:** 2006-03
- **Completion Date:** 2010-10
- **CT.gov Last Update:** 2015-10-08

## Brief Summary

Participants will receive PegIntron injection pen (Peginterferon alfa-2b) and Rebetol (Ribavirin) combination therapy as their usual medical treatment. The current study aims to evaluate whether the previously introduced, and now widely accepted and implemented educational program, which represents additional efforts in everyday practice to increase patient compliance, will succeed in achieving adherence rate in treated participants similar to the extent demonstrated by clinical trials.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Before inclusion, all participants must be informed and must give consent for the use of his/her anonymized health data related to his/her treatment with Peginterferon alfa-2b (injection pen) and Ribavirin.

Exclusion Criteria:

* According to Peginterferon alfa-2b/Ribavirin label.
```

## Arms

- **Chronic hepatitis C participants** — Untreated chronic hepatitis C (CHC) participants starting Peginterferon alfa-2b (injection pen) and Ribavirin combination therapy as their usual medical treatment according to the approved dosage/regimen were selected for this study.

## Interventions

- **PegIntron (Peginterferon alfa-2b)** (BIOLOGICAL) — Peginterferon alfa-2b (injection pen) administered according to the product's labeling and current practice in Hungary (1.5 micrograms \[mcg\]/killogram \[kg\]) for 12 weeks. Those participants whose continued treatment was warranted beyond week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
- **Rebetol (Ribavirin)** (DRUG) — Ribavirin capsules administered according to the product's labeling and current practice in Hungary (weight based daily) for 12 weeks. Those participants whose continued treatment was warranted beyond week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.

## Primary Outcomes

- **Number of Participants Who Are Triple-80 Compliant** _(time frame: 24 or 48 Weeks)_ — Participants who continued treatment beyond Week 12 (i.e., 24 or 48 weeks depending on the viral genotype) were assessed for triple-80 compliance. Triple-80 compliant, or simply compliant, participants were those that received \>= 80% of the planned total doses of both pegylated interferon alfa-2b and ribavirin for \>=80% of the duration of the therapy. 3 rates were computed: Compliance with study duration, compliance with pegylated interferon dose, and compliance with ribavirin dose. A participant was defined as triple-80 compliant, if none of the 3 rates as defined above were less than 80.

## Secondary Outcomes

- **Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up** _(time frame: 24 Weeks following completion of 24 or 48 weeks of therapy)_
- **Number Of Participants Self-Administering Pegylated Interferon Alfa-2b** _(time frame: Up to 48 Weeks)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00725205.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00725205*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*