AzTrials
AzTrials

Hepatitis CPhase 2NCT01467505

An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients

A Phase 2 study testing Telaprevir, Ribavirin and Pegylated Interferon Alfa-2a in people with Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 22 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

To assess efficacy of telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) for hepatitis C virus (HCV) in a 48-week total treatment duration regimen following liver transplantation. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis C
What is being tested?
Telaprevir, Ribavirin and Pegylated Interferon Alfa-2a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
22 sitesin 2 countries
Study dates
Feb 2012to Apr 2014
Phase
Phase 2
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female participants between the ages of 18 and 65 years
  • History of orthotopic liver transplantation less than 10 years before the Screening visit but no sooner than 6 months before Day 1
  • Taking a stable immunosuppressant regimen based on either tacrolimus or cyclosporine without substantial dose changes over the past 3 months
  • Naive to pegylated interferon/ribavirin treatment or experienced with pegylated interferon/ribavirin prior to transplantation with relapse, partial, or null response

Who cannot join

  • Documented cirrhosis after liver transplantation
  • Ascites or hepatic encephalopathy within 6 months before Screening
  • Retransplantation for recurrent hepatitis C
  • Treatment for hepatitis C post liver transplantation
  • History within the past 3 months of: rejection within 3 months or greater than (>) 1 rejection within 12 months
  • Current treatment with sirolimus or methylprednisolone. Low dose prednisone use (<5 milligram per day) is permitted
Show all 15Show fewer
  • History within 3 months of any bacterial infection requiring >1 week of intravenous antibiotics, cytomegalovirus viremia or cytomegalovirus infection with end-organ involvement, fungal disease (except cutaneous and mild oral thrush)
  • History of post transplant lymphoproliferative disease
  • Acceptable laboratory values at Screening as specified in the protocol
  • Positive for human immunodeficiency virus 1/2 (HIV1/2) enzyme immunoassay (EIA) antibody screen or Hepatitis B deoxyribonucleic acid (DNA) or Hepatitis B surface antigen
  • History of hepatocellular carcinoma with high risk of recurrence
  • Any other cause of liver disease deemed clinically significant by the investigator in addition to hepatitis C
  • Autoimmune-mediated disease
  • History of acute pancreatitis within 5 years before the Screening visit
  • Prior treatment with an hepatitis C virus (HCV) protease inhibitor

Trial locations and contacts

22 sites in 2 countries.

22 sites in 2 countries

United States20 sites

  • Michigan

    Ann Arbor, Michigan

  • Alabama

    Birmingham, Alabama

  • Florida

    Bradenton, Florida

  • Massachusetts

    Burlington, Massachusetts

  • North Carolina

    Charlotte, North Carolina

  • Ohio

    Cleveland, Ohio

  • Texas

    Dallas, Texas

  • Colorado

    Denver, Colorado

  • Michigan

    Detroit, Michigan

  • Illinios

    Evanston, Illinois

  • Texas

    Houston, Texas

  • Indiana

    Indianapolis, Indiana

  • California

    Los Angeles, California

  • Florida

    Miami, Florida

  • New York

    New York, New York

  • Nebraska

    Omaha, Nebraska

  • Pennsylvania

    Philadelphia, Pennsylvania

  • Arizona

    Phoenix, Arizona

  • New York

    Rochester, New York

  • Missouri

    St Louis, Missouri

Other trials in United States

Canada2 sites

  • Study site

    Calgary, Alberta

  • Study site

    Vancouver, British Columbia

Other trials in Canada

About this study

Official title: A 2-Part, Open Label Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Chronically Infected With Genotype 1 Hepatitis C Virus Following Liver Transplantation

To assess efficacy of telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) for hepatitis C virus (HCV) in a 48-week total treatment duration regimen following liver transplantation.

Conditions
Hepatitis C
Being tested
Telaprevir, Ribavirin, Pegylated Interferon Alfa-2a, Immunosuppressant Regimen
Medical subject headings
Hepatitis C

What participants receive

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

  • TelaprevirDrug

    Also called VX-950

    Tablet

  • RibavirinDrug

    Also called Copegus®, RBV

    Tablet

  • Pegylated Interferon Alfa-2aDrug

    Also called Pegasys®, Peg-IFN-alfa-2a

    Subcutaneous Injection

  • Immunosuppressant RegimenDrug

    Cyclosporine (CsA) based immunosuppressant regimen or Tacrolimus (TAC) based immunosuppressant regimen, as per standard practice. Immunosuppressant regimen were not considered study drugs.

Study groups in NCT01467505
Study groupRoleWhat they receive
T/PR + Immunosuppressant Regimen (Tacrolimus)ExperimentalParticipants who were receiving tacrolimus (TAC) based immunosuppressant regimen at baseline, received telaprevir (T) 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
Receives: Drug: Telaprevir; Drug: Ribavirin; Drug: Pegylated Interferon Alfa-2a; Drug: Immunosuppressant Regimen
T/PR + Immunosuppressant Regimen (Cyclosporine)ExperimentalParticipants who were receiving cyclosporine (CsA) based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
Receives: Drug: Telaprevir; Drug: Ribavirin; Drug: Pegylated Interferon Alfa-2a; Drug: Immunosuppressant Regimen

What is being measured

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

  1. Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)

    SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).

    Measured: 12 weeks after last planned dose of study drug (up to Week 60)

Secondary outcomes (11)

  1. Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)

    SVR24 was defined as an undetectable HCV RNA Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.

    Measured: 24 weeks after last planned dose of study drug (up to Week 72)

  2. Percentage of Participants With Rapid Viral Response (RVR)

    The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment.

    Measured: Week 4

  3. Percentage of Participants With Extended Rapid Viral Response (eRVR)

    The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment.

    Measured: Week 4 and Week 12

  4. Percentage of Participants With On-Treatment Virologic Failure

    On-treatment virologic failure was defined as subjects who met futility or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). Data for this outcome was not planned to be reported by prior response.

    Measured: Baseline up to Week 48

  5. Percentage of Participants With Viral Relapse

    Measured: 48 weeks

  6. Pharmacokinetics of Telaprevir, Peg-IFN, RBV , and Selected Immunosuppressant Medications (Tacrolimus and Cyclosporine)

    Measured: 48 weeks

  7. Percentage of Participants Requiring Dose Titration of Immunosuppressant Medications

    Measured: 48 weeks

  8. Percentage of Participants With Biopsy Confirmed and Treated Rejection

    Measured: 48 weeks

  9. Percentage of Participants With Histological Evidence of Stabilization or Improvement in Inflammation Grade or Fibrosis Stage

    Measured: 48 weeks

  10. Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region

    Measured: 48 weeks

  11. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Any adverse change from the participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.

    Measured: Baseline up to Week 52

Timeline

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

  1. First posted8 Nov 2011 (estimated)
  2. Study startFeb 2012
  3. Primary completionApr 2014
  4. Study completionApr 2014

Why it stopped: The study was terminated early by the sponsor on 13 January 2014 due to a decision to modify the drug development plan.

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01467505
Sponsor's protocol ID
VX11-950-117
Status last verified
Jun 2015
First submitted
3 Nov 2011
Last updated
18 Jun 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telaprevir, Ribavirin and Pegylated Interferon Alfa-2a in people with Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 22 sites in 2 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 15 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: stopped early, as of the sponsor's last update on 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 18 Jun 2015). 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 With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) (time frame: 12 weeks after last planned dose of study drug (up to Week 60)). 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 NCT01467505.

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 18 Jun 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in