---
title: An Observational Study of Pegasys in Dual- or Triple-Therapy in Patients With Chronic Hepatitis C
nct_id: NCT01679834
overall_status: COMPLETED
sponsor: Hoffmann-La Roche
study_type: OBSERVATIONAL
primary_condition: Hepatitis C, Chronic
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01679834.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01679834"
ct_last_update_post_date: 2018-03-01
last_seen_at: "2026-05-12T07:22:54.284Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# An Observational Study of Pegasys in Dual- or Triple-Therapy in Patients With Chronic Hepatitis C

**Official Title:** A Roche Project in Cooperation With the Bng (Association of German Resident Gastroenterologists) for Quality Assurance in the Dual- or Triple-therapy of Chronic Hepatitis C With Peg-(40kd)-Interferon Alfa 2a (Pegasys) at Hepatology Centers

**NCT ID:** [NCT01679834](https://clinicaltrials.gov/study/NCT01679834)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 7500
- **Lead Sponsor:** Hoffmann-La Roche
- **Conditions:** Hepatitis C, Chronic
- **Start Date:** 2014-11-24
- **Completion Date:** 2017-07-14
- **CT.gov Last Update:** 2018-03-01

## Brief Summary

This multicenter, observational study will assess the efficacy and the safety of Pegasys (peginterferon alfa 2a) in dual- or triple therapy in patients with chronic hepatitis C. Patients will receive Pegasys and/or ribavirin and/or a protease inhibitor according to local guidelines. Data will be collected for 96 weeks.

## Eligibility

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

```
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Diagnosis of chronic hepatitis C
* Patients receiving treatment with Pegasys and/or Copegus (ribavirin) and/or a protease inhibitor according to local label

Exclusion Criteria:

* Contraindications against Pegasys or Copegus
* Not willing or unable to sign written informed consent form
```

## Arms

- **Cohort**

## Primary Outcomes

- **Sustained virological response** _(time frame: 24 weeks after end of treatment)_

## Secondary Outcomes

- **Rapid virological response** _(time frame: 4 weeks after start of treatment)_
- **Early Virological Response** _(time frame: 12 weeks after start of treatment)_
- **Safety: incidence of adverse events** _(time frame: up to 24 weeks after end of treatment)_

## Locations (2)

- Hanover, Germany
- Herne, Germany

## 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)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|hanover||germany` — added _(2026-05-12)_
- `locations.|herne||germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01679834.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01679834*  
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