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New hepatitis c drug combo shows promise in early trial

NCT ID NCT01010646

Disease control Sponsor: ANRS, Emerging Infectious Diseases Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a new form of interferon (IFN alfa-2b XL) combined with ribavirin works better and causes fewer side effects than the standard treatment for chronic hepatitis C (genotypes 1 or 4). 84 adults who had not been treated before or had not responded to previous therapy took part. The main goal was to measure how much the virus level dropped after 4 and 12 weeks of treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

84 people

The number who actually took part.

Start date

Mar 2010

Finished

Jun 2013

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient having voluntarily signed the Informed Consent Form prior to any study specific procedure being performed * Male or female HCV genotype 1 or 4 infected patients (positive serum HCV RNA), aged between 18 and 65 years inclusive, with a body mass within the range over or equal of 45Kg and below or equal to 100 Kg * Patient being either naïve to therapy, either non-responder to previous standard Peg-interferon α + ribavirin therapy, * With no absolute contra-indication to interferon α or ribavirin * Female patients must be non-lactating and of non-childbearing potential, or have a negative pregnancy test results to enter the study * No evidence of acute or advanced liver disease, uncontrolled diabetes, cardiovascular, immunological, or thyroid disease, and no recently diagnosed malignancy * Vital signs within normal ranges, or if outside the normal ranges, not deemed clinically significant in the opinion of the Investigator. An ECG with no clinically significant abnormalities Exclusion Criteria: * History of solid organ transplantation * Severe systemic infection, uncontrolled diabetes, cancers, associated liver disease * General anesthesia or recent blood transfusion

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Conditions

The condition(s) this trial relates to.

chronic hepatitis C virus infection hepatitis C virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic hepatitis C

Contacts and locations

Locations

  • Hôpital de la Croix Rousse

    Lyon, 69004, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.