---
title: A Study of Vaniprevir (MK-7009) in Participants With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028)
nct_id: NCT00943761
overall_status: COMPLETED
phase: PHASE2
sponsor: Merck Sharp & Dohme LLC
study_type: INTERVENTIONAL
primary_condition: Hepatitis C, Chronic
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00943761.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00943761"
ct_last_update_post_date: 2021-02-08
last_seen_at: "2026-05-12T06:17:16.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of Vaniprevir (MK-7009) in Participants With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028)

**Official Title:** A Phase II Open Label Study of MK-7009 Administered Concomitantly With Pegylated Interferon Alfa-2a and Ribavirin to Patients With Chronic Hepatitis C Infection After Participation in Other MK-7009 Clinical Trials

**NCT ID:** [NCT00943761](https://clinicaltrials.gov/study/NCT00943761)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 45
- **Lead Sponsor:** Merck Sharp & Dohme LLC
- **Conditions:** Hepatitis C, Chronic
- **Start Date:** 2009-10-23
- **Completion Date:** 2013-05-29
- **CT.gov Last Update:** 2021-02-08

## Brief Summary

This study will provide vaniprevir 600 mg or 300 mg twice daily in combination with pegylated interferon (peg-IFN) and ribavirin (RBV) to participants with chronic hepatitis C virus (HCV) infection who did not achieve viral eradication while participating in a prior vaniprevir clinical trial (MK-7009-004, NCT00518622; MK-7009-007, NCT00704405; MK-7009-009, NCT00704184; and MK-7009-029, NCT00954993).

## Eligibility

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

```
Inclusion criteria:

* Participant has participated in a prior vaniprevir clinical trial
* Participant agrees to use acceptable birth control method during treatment

Exclusion criteria:

* More than one year has passed since the participant was determined to be eligible for enrollment in protocol 028
* Participant discontinued vaniprevir and/or peg-IFN and/or RBV in the prior study due to a safety or tolerability issue
* Participant received any investigational therapy for HCV after participating in the prior study
```

## Arms

- **Vaniprevir 300 mg b.i.d. + peg-IFN + RBV** (EXPERIMENTAL) — Participants received vaniprevir 300 mg twice daily (b.i.d.) in combination peg-IFN 180 mcg weekly and ribavirin (1000 or 1200 mg) administered as a divided dose twice daily.
- **Vaniprevir 600 mg b.i.d. + peg-IFN + RBV** (EXPERIMENTAL) — Participants received vaniprevir 600 mg b.i.d. in combination peg-IFN 180 mcg weekly and ribavirin (1000 or 1200 mg) administered as a divided dose twice daily.

## Interventions

- **Vaniprevir 600 mg b.i.d.** (DRUG) — Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks
- **Vaniprevir 300 mg b.i.d.** (DRUG) — Oral capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks
- **Pegylated interferon** (DRUG) — Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks
- **Ribavirin** (DRUG) — Oral tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight (\<75 kg or ≥75 kg, respectively), for 48 weeks

## Primary Outcomes

- **Number of Participants Who Experienced an Adverse Event** _(time frame: up to 72 weeks)_ — An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
- **Number of Participants Who Experienced a Serious Adverse Event** _(time frame: up to 72 weeks)_ — Serious adverse event is defined as any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly or birth defect, was a cancer, or was an overdose.
- **Number of Participants Who Discontinued Study Treatment Due to an Adverse Event** _(time frame: 48 weeks)_ — An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
- **Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24)** _(time frame: 72 weeks)_ — SVR24 is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) 24 weeks after the end of vaniprevir study therapy. HCV RNA plasma levels were assessed using the Roche COBAS Taqman assay (or equivalent) with the limit of quantification (LoQ) of at least 25 IU/mL and the limit of detection (LoD) of at least 10 IU/mL.

## 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.phases` — 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)_
- `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/NCT00943761.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00943761*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*