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Hepatitis C VirusPhase 3MAGNITUDENCT01741545

Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia

A Phase 3 study testing Pegylated-Interferon-lambda, Ribavirin and Daclatasvir in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 32 sites in 8 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

The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3 Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Hepatitis C Virus
What is being tested?
Pegylated-Interferon-lambda, Ribavirin and Daclatasvir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
32 sitesin 8 countries
Study dates
31 Mar 2013to 31 Jan 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Severe hemophilia (defined as < 1% factor activity level)
  • Infection with the hepatitis C virus (HCV) with underlying hemophilia
  • Males 18 years of age and above
  • Have not been previously treated with an interferon

Who cannot join

  • Not infected with the hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Chronic liver disease caused by any disease other than chronic HCV infection
  • Presence of Bethesda inhibitor
  • Current evidence of or history of portal hypertension

Trial locations and contacts

32 sites in 8 countries.

32 sites in 8 countries

France6 sites

  • Local Institution

    Grenoble, 38043

  • Local Institution

    Lyon, 69317

  • Local Institution

    Montpellier, 34295

  • Local Institution

    Paris, 75651

  • Local Institution

    Paris, 75679

  • Local Institution

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Australia5 sites

  • Local Institution

    Adelaide, South Australia, 5000

  • Local Institution

    Camperdown, New South Wales, 2050

  • Local Institution

    Herston, Queensland, 4029

  • Local Institution

    Herston, 4029

  • Local Institution

    Melbourne, Victoria, 3004

Other trials in Australia

United States4 sites

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Clinical Research Centers Of America

    Murray, Utah, 84123

  • Stanford Boswell Clinic

    Palo Alto, California, 94304

  • Hospital Of The University Of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

Italy4 sites

  • Local Institution

    Florence, 50134

  • Local Institution

    Milan, 20122

  • Local Institution

    Roma, 00185

  • Local Institution

    Torino, 10126

Other trials in Italy

Netherlands4 sites

  • Local Institution

    Amsterdam, 1105 AZ

  • Local Institution

    Nijmegen, 6525 GA

  • Local Institution

    Rotterdam, 3015 CE

  • Local Institution

    Utrecht, 3508 GA

Other trials in Netherlands

Romania4 sites

  • Local Institution

    Bucharest, 50524

  • Local Institution

    Constanța, 900635

  • Local Institution

    Iași, 700116

  • Local Institution

    Iași, 700506

Other trials in Romania

Spain3 sites

  • Local Institution

    Barcelona, 08035

  • Local Institution

    Madrid, 28046

  • Local Institution

    Seville, 41013

Other trials in Spain

Russia2 sites

  • Local Institution

    Moscow, 107996

  • Local Institution

    Saint Petersburg, 191186

Other trials in Russia

About this study

Official title: A Phase 3 Study Evaluating the Safety and Efficacy of Lambda/Ribavirin/Daclatasvir in Subjects With Chronic HCV Infection and Underlying Hemophilia Who Are Treatment Naïve or Are Prior Relapsers to Peginterferon Alfa-2a/Ribavirin

The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3

Being tested
Pegylated-Interferon-lambda, Ribavirin, Daclatasvir
Medical subject headings
Hepatitis C

What participants receive

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

  • Pegylated-Interferon-lambdaBiological

    Also called pegIFNλ, BMS-914143

  • RibavirinDrug

  • DaclatasvirDrug

    Also called BMS-790052

Study groups in NCT01741545
Study groupRoleWhat they receive
Cohort A: Genotype-2,-3 (Lambda/RBV/DCV)ExperimentalLambda 180 μg solution for subcutaneous (SC) injection, once weekly for 12 weeks Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 12 weeks Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks
Receives: Biological: Pegylated-Interferon-lambda; Drug: Ribavirin; Drug: Daclatasvir
Cohort B: Genotype-1b,-4 (Lambda/RBV/DCV)ExperimentalLambda 180 μg solution for subcutaneous (SC) injection, once weekly for 24 weeks Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 24 weeks Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks
Receives: Biological: Pegylated-Interferon-lambda; Drug: Ribavirin; Drug: Daclatasvir

What is being measured

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

  1. Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12

    SVR12 was defined as HCV ribonucleic acid (RNA) less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.

    Measured: Follow-up Week 12

Secondary outcomes (8)

  1. Percentage of Participants With Rapid Virologic Response (RVR)

    RVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 4.

    Measured: Treatment Week 4

  2. Percentage of Participants With Complete Early Virologic Response (cEVR)

    cEVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 12.

    Measured: Treatment Week 12

  3. Percentage of Participants With End of the Treatment Response (EOTR)

    EOTR was defined as HCV RNA less than the lower limit of quantitation, target not detected at end of treatment.

    Measured: End of the treatment (Week 12 for Cohort A, Week 24 for Cohort B)

  4. Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24)

    SVR24 was defined as HCV RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.

    Measured: Follow-up Week 24

  5. Percentage of Participants With Treatment-Emergent Cytopenic Abnormalities On-Treatment

    Cytopenic abnormalities were defined as anemia: Hemoglobin (Hb) <10 g/dL, and/or neutropenia: absolute neutrophils and bands (ANC) <750 mm^3, and/or thrombocytopenia: platelets <50,000 mm^3.

    Measured: After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)

  6. Percentage of Participants With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment

    Flu-like symptoms were defined as pyrexia or chills or pain. Musculoskeletal symptoms were defined as arthralgia or myalgia or back pain.

    Measured: After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)

  7. Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death

    AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug.

    Measured: From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)

  8. Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities

    Laboratory abnormalities were determined and graded using the Division of acquired immunodeficiency syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0. International Normalized Ratio (INR): >2.0*Upper limit of normal (ULN); Alanine aminotransferase (ALT) : >5*ULN; Aspartate aminotransferase (AST): >5*ULN; Prothrombin Time (PT): >1.50*ULN; Bilirubin (Total): >2.5*ULN; Triglycerides (fasting): >750 mg/dL.

    Measured: After day 1 to to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)

Timeline

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

  1. First posted5 Dec 2012 (estimated)
  2. Study start31 Mar 2013
  3. Primary completion31 Jan 2015
  4. Study completion31 Jan 2015

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01741545
Sponsor's protocol ID
AI452-030
Other IDs
2012-003463-22
Acronym
MAGNITUDE
Status last verified
Aug 2020
First submitted
3 Dec 2012
Last updated
11 Aug 2020
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pegylated-Interferon-lambda, Ribavirin and Daclatasvir in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 32 sites in 8 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 4 inclusion and 4 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 11 Aug 2020. 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 France, Australia, United States, Italy, Netherlands and 3 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12 (time frame: Follow-up Week 12). 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 NCT01741545.

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 11 Aug 2020.

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