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Hepatitis C, ChronicPhase 2NCT01278134

A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir With or Without Copegus (Ribavirin) in Interferon-Naïve Patients With Chronic Hepatitis C Genotype 1 (INFORM-SVR)

A Phase 2 study testing RO5024048, danoprevir and peginterferon alfa-2a [Pegasys] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 32 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
RO5024048, danoprevir and peginterferon alfa-2a [Pegasys]
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
170 participants
Where
32 sitesin 4 countries
Study dates
Feb 2011to Oct 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patient, >/= 18 years of age
  • Chronic Hepatitis C of >/= 6 months duration at screening
  • HCV genotype 1 and quantifiable HCV RNA at screening (Roche COBAS TaqMan HCV test)
  • Naïve for treatment with interferon (pegylated or non-pegylated)
  • Body Mass Index (BMI) 18-35 inclusive, minimum weight 45 kg
  • Females of child-bearing potential and males with female partners of childbearing potential must use 2 forms of effective non-hormonal contraception

Who cannot join

  • Pregnant or lactating women and males with female partners who are pregnant or lactating
  • Decompensated liver disease or impaired liver function
  • Cirrhosis or incomplete/transition to cirrhosis
  • Non-hepatitis C chronic liver disease
  • Hepatitis B or HIV infection
  • History of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin
  • History of pre-existing renal disease (except for nephrolithiasis) or severe cardiac disease
  • History of drug or alcohol abuse within the last year or alcohol consumption of > 2 units per day; cannabinoid use is excepted

Trial locations and contacts

32 sites in 4 countries.

32 sites in 4 countries

United States18 sites

  • Study site

    Albuquerque, New Mexico, 87131

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Honolulu, Hawaii, 96814

  • Study site

    Honolulu, Hawaii, 96817

  • Study site

    Houston, Texas, 77030

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    La Jolla, California, 92037-1030

  • Study site

    Lutherville, Maryland, 21093

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Nashville, Tennessee, 37211

  • Study site

    New York, New York, 10021

  • Study site

    Newark, New Jersey, 07102

  • Study site

    Newport News, Virginia, 23602

  • Study site

    Orlando, Florida, 32809

  • Study site

    Providence, Rhode Island, 02905

  • Study site

    Sacramento, California, 95817

  • Study site

    Vancouver, Washington, 98664

Other trials in United States

Germany7 sites

  • Study site

    Berlin, 10969

  • Study site

    Berlin, 13353

  • Study site

    Frankfurt am Main, 60590

  • Study site

    Hamburg, 20099

  • Study site

    Hanover, 30625

  • Study site

    Kiel, 24146

  • Study site

    Leipzig, 04103

Other trials in Germany

France6 sites

  • Study site

    Clichy, 92118

  • Study site

    Créteil, 94010

  • Study site

    Lille, 59037

  • Study site

    Marseille, 13285

  • Study site

    Montpellier, 34295

  • Study site

    Paris, 75651

Other trials in France

New Zealand1 site

  • Study site

    Grafton, 1010

Other trials in New Zealand

About this study

Official title: INFORM-SVR: A Randomized, Multi-Center Study of Interferon-Free Treatment With a Combination of a Polymerase Inhibitor (RO5024048) and a Ritonavir Boosted HCV Protease Inhibitor (RO5190591/r, DNV/r) With or Without Copegus® in Interferon Naïve HCV Genotype 1 Infected Patients

This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1. In arm A and B, interferon treatment-naïve patients will receive 1000 mg RO5024048 orally twice daily and 100 mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200 mg orally daily) or placebo for 12 weeks. Depending on viral response and treatment arm patients will be re-randomized to continue assigned treatment for additional 12 weeks or stop all treatment. The anticipated time on study treatment is up to 24 weeks plus a 24-week follow-up.

As of 29. September 2011, Arm B patients (placebo-containing arm) will be offered, in conjunction with the current treatment, Pegasys (peginterferon alfa-2a) 180 mcg subcutaneously weekly plus Copegus 1000mg or 1200 mg orally daily for 24 weeks, with a 24-week follow-up.

Being tested
Copegus placebo, RO5024048, danoprevir, peginterferon alfa-2a [Pegasys], ribavirin [Copegus]
Medical subject headings
Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Copegus placeboDrug

    1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks

  • RO5024048Drug

    1000 mg bid orally, up to 24 weeks

  • danoprevirDrug

    100 mg bid orally, up to 24 weeks

  • peginterferon alfa-2a [Pegasys]Drug

    180 mcg sc weekly, 24 weeks

  • ribavirin [Copegus]Drug

    1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks

  • ritonavirDrug

    100 mg bid orally, up to 24 weeks

Study groups in NCT01278134
Study groupRoleWhat they receive
Arm B ExtensionExperimentalAll patients in treatment arm B were offered to receive Pegasys/Cogepus therapy for an additional 24 weeks.
Receives: Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus]
RO5024048 & ritonavir-boosted danoprevir without Ribavirin (B)ExperimentalNot described
Receives: Drug: Copegus placebo; Drug: RO5024048; Drug: danoprevir; Drug: ritonavir
RO5024048 and ritonavir-boosted danoprevir with Ribavirin (A)ExperimentalNot described
Receives: Drug: RO5024048; Drug: danoprevir; Drug: ribavirin [Copegus]; Drug: ritonavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sustained virological response, defined as undetectable HVC RNA measured by Roche COBAS TaqMan HCV test

    Measured: 24 weeks after end of treatment

  2. Safety: Incidence of adverse events

    Measured: 1.5 years

Secondary outcomes (7)

  1. Virological response (HCV RNA measured by Roche COBAS Taqman HCV test)

    Measured: up to 48 weeks

  2. Impact of Copegus (ribavirin) on efficacy of the direct-acting antiviral combination regimen: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test)

    Measured: 1.5 years

  3. Comparison of 12 and 24 weeks of treatment duration: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test)

    Measured: 1.5 years

  4. Pharmacokinetics: Plasma concentrations of danoprevir, ritonavir, RO4995855 (parent drug of RO5024048) and ribavirin

    Measured: up to 24 weeks

  5. Viral resistance: HCV RNA sequencing and phenotypic analyses

    Measured: up to 48 weeks

  6. Effect of interleukin 28B genotype on efficacy: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test)

    Measured: 1.5 years

  7. Quality of life: SF-36 questionnaire, Fatigue Severity Scale

    Measured: up to 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01278134
Sponsor's protocol ID
PP25213
Other IDs
2010-022067-35
Status last verified
Nov 2016
First submitted
14 Jan 2011
Last updated
2 Nov 2016
Results posted
No

Publications

  • Tong X, Li L, Haines K, Najera I. Identification of the NS5B S282T resistant variant and two novel amino acid substitutions that affect replication capacity in hepatitis C virus-infected patients treated with mericitabine and danoprevir. Antimicrob Agents Chemother. 2014 Jun;58(6):3105-14. doi: 10.1128/AAC.02672-13. Epub 2014 Mar 17.

    PubMed 24637689

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RO5024048, danoprevir and peginterferon alfa-2a [Pegasys] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 32 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Germany, France, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustained virological response, defined as undetectable HVC RNA measured by Roche COBAS TaqMan HCV test (time frame: 24 weeks after end of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01278134, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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