---
title: A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)
nct_id: NCT01458535
overall_status: COMPLETED
phase: PHASE2
sponsor: AbbVie (prior sponsor, Abbott)
study_type: INTERVENTIONAL
primary_condition: Hepatitis C Virus
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01458535.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01458535"
ct_last_update_post_date: 2016-07-11
last_seen_at: "2026-05-12T06:00:21.831Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)

**Official Title:** An Open-Label, Sequential Arm, Multicenter Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-267 With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) Infection

**NCT ID:** [NCT01458535](https://clinicaltrials.gov/study/NCT01458535)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 61
- **Lead Sponsor:** AbbVie (prior sponsor, Abbott)
- **Conditions:** Hepatitis C Virus
- **Start Date:** 2011-09
- **Completion Date:** 2013-05
- **CT.gov Last Update:** 2016-07-11

## Brief Summary

The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve participants with genotype 1, 2 or 3 chronic HCV infection.

## Detailed Description

This was a 2 sequential arm, combination treatment study where each arm contained 3 cohorts: one each for HCV genotype 1, 2, and 3. The study consisted of 2 phases, a treatment phase and a post-treatment phase. The treatment phase was designed to explore the antiviral activity, safety and pharmacokinetics of ABT-450/r dosed in combination with ABT-267 with and without RBV for up to 12 weeks. The post-treatment phase was designed to monitor and evaluate Sustained Virologic Response (SVR) 12, SVR 24, and the evolution and persistence of viral resistance to ABT-267 and ABT-450 in HCV genotype 1-, 2-, and 3-infected participants who have been exposed to ABT-267 and ABT-450/r. Arms 1 and 2 were enrolled sequentially.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Participants who had a body mass index 18 to \< 35 kg/m\^2.
* Females were either postmenopausal for at least 2 years, surgically sterile, or willing to use at least 2 effective forms of birth control.
* Males must have been surgically sterile or agreed to use at least 2 effective forms of birth control throughout the course of the study.
* Participants were in a condition of general good health, other than the HCV infection.
* Participants had a chronic HCV genotype 1, 2, or 3 infection for at least 6 months, a plasma HCV RNA \> 50,000 IU/mL, and FibroTest score \<= 0.72 and aspartate aminotransferase (AST) to platelet ratio index \<= 2, Fibroscan® result of \< 9.6 kilopascal (kPa), or absence of cirrhosis based on a liver biopsy.

Exclusion Criteria:

* Positive drug screen
* Previous use of anti-HCV agents
* History of cardiac disease
* History of uncontrolled diabetes or diabetes requiring insulin
* Abnormal laboratory results
* Females who were pregnant or planned to become pregnant within 6 months after their last dose of study drug/RBV or were breastfeeding; males whose partners were pregnant or would become pregnant within 6 months after their last dose of study drug/RBV
* Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus (HIV) antibody (Ab). Negative HIV status was to be confirmed at screening.
```

## Arms

- **ABT-450/r and ABT-267 plus RBV in genotype 1 participants** (EXPERIMENTAL) — ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve participants with HCV genotype 1 infection.
- **ABT-450/r and ABT-267 plus RBV in genotype 2 participants** (EXPERIMENTAL) — ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 2 infection.
- **ABT-450/r and ABT-267 plus RBV in genotype 3 participants** (EXPERIMENTAL) — ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 3 infection.
- **ABT-450/r and ABT-267 in genotype 1 participants** (EXPERIMENTAL) — ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 1 infection.
- **ABT-450/r and ABT-267 in genotype 2 participants** (EXPERIMENTAL) — ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 2 infection.
- **ABT-450/r and ABT-267 in genotype 3 participants** (EXPERIMENTAL) — ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 3 infection.

## Interventions

- **ABT-450** (DRUG) — tablets
- **ABT-267** (DRUG) — tablets
- **ribavirin** (DRUG) — tablets
- **ritonavir** (DRUG) — capsules

## Primary Outcomes

- **Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)]** _(time frame: Week 4 through Week 12)_ — Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (\< 25 IU/mL). Participants with missing data were imputed as failures.

## Secondary Outcomes

- **Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment** _(time frame: Post-treatment Day 1 to Post-treatment Week 12)_
- **Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment** _(time frame: Post-treatment Day 1 to Post-treatment Week 24)_
- **Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)** _(time frame: Week 2)_
- **Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR)** _(time frame: Week 4)_
- **Percentage of Participants With Virologic Failure During Treatment** _(time frame: Day 1 through Week 12)_
- **Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks)** _(time frame: Post-treatment Day 1 to Post-treatment Week 48)_

## 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.maxAge` — 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/NCT01458535.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01458535*  
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