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Liver TransplantationPhase 3NCT00378599

Effects of Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation in Subjects With Chronic Hepatitis C Recurrence (P04590AM3)(COMPLETED)

A Phase 3 study testing Combination of (a) pegylated interferon alfa-2b and (b) rebetol in people with Liver Transplantation and Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.

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 is an exploratory study and is a Phase 3, single-arm, multi-center, open-label study of pegylated interferon alfa-2b, PEG-IFN alpha-2b (PEG-Intron) and ribavirin (RBV) to determine the sustained virologic response (SVR) at 24-week follow-up to 48 week in subjects after orthotopic liver transplantation (OLT) with… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Combination of (a) pegylated interferon alfa-2b and (b) rebetol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
No sites listed yet
Study dates
May 2006to Jul 2009
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must confirm that all prior medication washout times have been observed.
  • Subject must be 18 - 70 years of age of either gender and of any race.
  • Subject must be transplanted for end-stage hepatitis C or fulminant hepatitis C.
  • Subject must have documented:
  • persistent HCV viremia after OLT as defined by plasma positive for HCV RNA by quantitative reverse transcription-polymerase chain reaction (RT-PCR),
  • A liver transplant performed at least 3 months prior to screening but not more than 3 years prior to screening.
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  • Subject must be on stable doses of immunosuppression for at least 1 month.
  • Compensated liver disease with minimum hematologic, biochemical, and serologic criteria at the (Day 1) baseline visit.
  • Alpha-fetoprotein value (AFP) less than or equal to 250ng/mL. If AFP greater than 100 ng/mL, patient will need evidence of normal liver (magnetic resonance imaging) MRI and normal chest computerized tomography (CT) scan within the last 3 months or during the screening period.
  • For subjects with a history of diabetes or hypertension, clearance from an ophthalmologist has to be obtained prior to treatment start (Day 1/Visit 2).
  • Subjects with a history of mild depression may be considered for entry into this study.
  • Female subjects cannot be pregnant or breastfeeding and must be either postmenopausal, surgically sterile or using 2 methods of birth control.
  • Sexually active male subjects are practicing an acceptable, method of contraception.
  • Contraceptive measures will be reviewed with female subjects at each visit. Dual methods of contraception must be used for 1 month prior to the start of treatment and 6 months after treatment discontinuation.
  • Pregnancy tests obtained at Screen Visit and Day 1 Visit prior to the initiation of treatment must be negative.

Who cannot join

  • Pregnant women, women who plan to become pregnant, male subjects whose partner wants to become pregnant, and breastfeeding women (during study and up to 6 months after study completion).
  • Subject has used any investigational product within 30 days prior to Screening or is participating in any other clinical study.
  • Prior treatment for chronic hepatitis C post-liver transplant, including but not limited to antiviral or immunomodulatory product, any interferon product, or RBV, either as monotherapy or in combination.
  • Subjects with other organ transplants.
  • Any subject who received a positive hepatitis C core antibody (HBcAb) or HCV positive donor liver graft.
  • Retransplantation of the liver for rejection or graft failure.
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  • Evidence of decompensated liver disease.
  • Known coagulopathies including hemophilia.
  • Known hemoglobinopathies.
  • Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Hypersensitivity to alpha interferon and/or RBV.
  • Co-infection with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).
  • Evidence of active or suspected malignancy or a history of malignancy within the last 5 years (with the exception of pre-transplant hepatocellular carcinoma histologically within the Milan criteria, and adequately treated basal or squamous cell carcinoma of the skin).
  • Any known pre-existing medical condition that could interfere with the subject's participation in and completion of the study.
  • Subject is or was a substance abuser. Subjects treated with buprenorphine (Subutex) who have been stable for 6 months may be included.
  • Patients weighing over 135 kg;
  • Is participating in any other clinical study(ies);
  • Is allergic to or has sensitivity to the study drug or its excipients.

About this study

Official title: PROTECT - Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation: Efficacy and Safety in Hepatitis C Recurrence Therapy

This is an exploratory study and is a Phase 3, single-arm, multi-center, open-label study of pegylated interferon alfa-2b, PEG-IFN alpha-2b (PEG-Intron) and ribavirin (RBV) to determine the sustained virologic response (SVR) at 24-week follow-up to 48 week in subjects after orthotopic liver transplantation (OLT) with chronic hepatitis C (HCV) recurrence.

Being tested
Combination of (a) pegylated interferon alfa-2b and (b) rebetol
Medical subject headings
Hepatitis C, Chronic, Liver Cirrhosis

What participants receive

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

  • Combination of (a) pegylated interferon alfa-2b and (b) rebetolDrug

    Also called (a) SCH 54031, PEG-Intron, (b) SCH 18908, Rebetol

    1. Powder for injection in vials and Redipen (50, 80, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
    2. 200 mg capsules, oral, weight based dose of 400-1200 mg, daily for up to 48 weeks
Study groups in NCT00378599
Study groupRoleWhat they receive
PEG-Intron plus Rebetol (RBV)ExperimentalPEG-Intron plus RBV treatment for up to 48 weeks with 24-week follow up. SCH 54031 PEG-Intron 1.5 ug/kg SC per week plus SCH 18908 REBETOL twice daily (BID) PO with food, dosed as followed: Weeks 1 and 2, RBV Dose 400 mg (2 capsules, 1 AM and 1 PM). At the end of Weeks 2 and 4 of Treatment (tx), a complete blood count (CBC) was performed. An increase in RBV dose was permitted only if the hemoglobin was >10 g/dL. At Weeks 3 and 4, RBV dose was 800 mg (4 capsules, 2 AM and 2 PM). From Weeks 5 to 48, RBV doses could be increased based on subject body weight. For subjects weighing <65 kg, maximum dose of RBV was to be 800 mg (4 capsules, 2 AM and 2 PM), for subjects weighing 65-85 kg, max dose of RBV was 1000 mg/day (5 capsules, 2 AM and 3 PM), for subjects weighing >85 kg, max dose of RBV was 1200 mg/day, 6 capsules, 3 AM and 3 PM).
Receives: Drug: Combination of (a) pegylated interferon alfa-2b and (b) rebetol

What is being measured

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

  1. A Sustained Virologic Response (SVR), Defined as a Plasma HCV RNA Level Below the Lower Level of Quantitation (LLQ) at 24 Weeks Post-treatment

    Number of participants with SVR at 24-week follow up after treatment with PEG-Intron and Ribavirin in post-orthotopic liver transplant recipients with recurrent HCV.

    Measured: 24 weeks after completion of up to 48 weeks of therapy

Timeline

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

  1. First posted20 Sep 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionJul 2009
  4. Study completionJul 2009

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
Single group
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00378599
Sponsor's protocol ID
P04590
Status last verified
Mar 2017
First submitted
18 Sep 2006
Last updated
6 Apr 2017
Data monitoring committee
No
Individual data sharing
Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

  • Gordon FD, Kwo P, Ghalib R, Crippin J, Vargas HE, Brown KA, Schiano T, Chaudhri E, Pedicone LD, Brown RS Jr. Peginterferon-alpha-2b and ribavirin for hepatitis C recurrence postorthotopic liver transplantation. J Clin Gastroenterol. 2012 Sep;46(8):700-8. doi: 10.1097/MCG.0b013e31825833be.

    PubMed 22739223

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Combination of (a) pegylated interferon alfa-2b and (b) rebetol in people with Liver Transplantation and Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.

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 15 inclusion and 18 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 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

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 16 Jul 2010). 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?

A Sustained Virologic Response (SVR), Defined as a Plasma HCV RNA Level Below the Lower Level of Quantitation (LLQ) at 24 Weeks Post-treatment (time frame: 24 weeks after completion of up to 48 weeks of therapy). 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 NCT00378599, 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 6 Apr 2017.

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