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A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C

NCT ID: NCT01371162

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-12-31

Brief Summary

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This 2-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with hepatitis C infection. Cohorts will be randomized to receive either RO5428029 in ascending doses or placebo for up to 7 days (patients) or up to 14 days (healthy volunteers).

Detailed Description

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Conditions

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Hepatitis C, Chronic, Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A1 Healthy Volunteers

Group Type EXPERIMENTAL

RO5428029

Intervention Type DRUG

Multiple ascending doses

A2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

multiple doses

B1 HCV Infection

Group Type EXPERIMENTAL

RO5428029

Intervention Type DRUG

Multiple ascending doses

B2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

multiple doses

Interventions

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RO5428029

Multiple ascending doses

Intervention Type DRUG

placebo

multiple doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects (Part A) or patients with chronic hepatitis C infection (Part B), 18 to 60 years of age, inclusive
* Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a minimum weight of 45 kg
* Female subjects/patients must be surgically sterile or post-menopausal
* Male subjects/patients and their partners of childbearing potential must use 2 methods of contraception
* For HCV patients:
* Hepatitis C genotype 1 of \> 6 months duration at screening
* HCV RNA quantifiable (Roche COBAS TaqMan HCV Test) at screening
* HCV treatment-naïve (no prior antiviral therapy for chronic hepatitis C with interferon-based therapy)
* Liver biopsy or non-invasive procedure within the past 2 years showing absence of cirrhosis

Exclusion Criteria

* Pregnant or lactating women, and male partners of women who are pregnant or lactating
* Positive test for drugs of abuse
* History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams or 1 unit of alcohol
* History or symptoms of any significant disease or disorder
* History of active malignancy within the last 5 years, except for localized or in situ carcinoma (e.g. basal or squamous cell carcinoma of the skin)
* Positive for hepatitis B or HIV infection, and/ or for HCV for healthy volunteers (Part A)
* For HCV patients:
* Decompensated liver disease or impaired liver function as defined by any history of ascites, hepatic encephalopathy, hepatocellular carcinoma or bleeding esophageal varices, or prothrombin international normalized ratio (PTINR) \>/= 2.0 at screening
* Evidence of cirrhosis and/or incomplete transition to cirrhosis
* Presence or history of non-hepatitis C liver disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Montpellier, , France

Site Status

Strasbourg, , France

Site Status

Leiden, , Netherlands

Site Status

Chorzów, , Poland

Site Status

Warsaw, , Poland

Site Status

Wroclaw, , Poland

Site Status

Countries

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Romania France Netherlands Poland

Other Identifiers

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NP25733

Identifier Type: -

Identifier Source: org_study_id