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Hepatitis C, ChronicPhase 3PegadeNCT00237484

Effect of Infliximab on the Efficacy of Peg-Intron/Ribavirin in Patients With Hepatitis C (Study P04257AM4)(COMPLETED)

A Phase 3 study testing Induction dose of (a) infliximab followed by combination of (b) pegylated interferon alfa-2b and (c) ribavirin and Combination of (a) pegylated interferon alfa-2b and (b) ribavirin in people with 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 a Phase IIIB, randomized, prospective, multicenter, single-country, open-label, controlled pilot trial designed to evaluate the effect of infliximab induction therapy on sustained virologic response (SVR) to treatment with pegylated interferon alfa-2b plus ribavirin in a group of 96 therapy-naïve subjects with… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
Induction dose of (a) infliximab followed by combination of (b) pegylated interferon alfa-2b and (c) ribavirin and Combination of (a) pegylated interferon alfa-2b and (b) ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
No sites listed yet
Study dates
18 Jul 2005to 30 Jun 2011
Phase
Phase 3
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
  • Subjects must be 18 to 65 years of age.
  • HCV genotype 1 (including mixtures of subtypes of genotype 1).
  • Naïve to interferon (any formulation) and ribavirin.
  • Serum TNF-alpha >300 pg/mL(single measure at Pre-Screen Visit).
  • HCV ribonucleic acid (RNA) positive.
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  • Any alanine aminotransferase (ALT) level.
  • Fasting glucose should be 3.8-6.2 mmol/L. Results between 6.3-7.8 mmol/L require a HbA1c <=8.5%. All diabetic subjects must have an HbA1c <=8.5%, whether on medication or diet controlled.
  • Liver biopsy within 24 months of enrolment demonstrating Stage 0-3 fibrosis (Metavir System).
  • Compensated liver disease with the following minimum hematological, biochemical, and serological criteria at the screen visit (WNL = within normal limits):
  • Hemoglobin values of equal or more than 12 g/dL for females and 13 g/dL for males.
  • White blood cell (WBC) count equal to or more than 3,000/mm**3
  • Neutrophil count equal to or more than 1,500/mm**3
  • Platelet count equal to or more than 80,000/mm**3
  • Total bilirubin WNL
  • Indirect bilirubin WNL (unless non-hepatitis related factors such as Gilbert's disease explain an indirect bilirubin rise). In such cases indirect bilirubin should be less than or equal to 50 µmol/L
  • Albumin WNL
  • Serum creatinine WNL
  • Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be willing to use an acceptable method of birth control, deemed acceptable by the investigator, (e.g., hormonal contraceptive, medically prescribed intrauterine device (IUD), condom in combination with spermicidal) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
  • Subjects must understand and be able to adhere to the dosing and visit schedules, and agree to record, study medication compliance, concomitant medications, and adverse events accurately and consistently in a daily diary.

Who cannot join

  • Women who are pregnant or nursing.
  • Subjects who have not observed the designated washout periods for any of the prohibited medications.
  • Subjects who have used any investigational product within 30 days prior to enrollment.
  • Acute HCV infection defined as infection for <6 months.
  • Male partners to/or Heterosexually active women of childbearing potential not practicing a highly effective form of contraception.
  • Positive screening for tuberculosis (TB) or Tuberculin Skin Test > 5mm.
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  • History or presence of cirrhosis (Stage 4 on Metavir System) and/or complication such as ascites, bleeding varices or hepatic encephalopathy
  • Active hepatitis B virus (HBV) infection (hepatitis B surface antigen [HBsAg] positive).
  • Any known pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study such as:
  • Pre-existing psychiatric condition, including but not limited to moderate to severe depression, or a history of severe psychiatric disorders, such as psychosis, suicidal ideation and/or suicidal attempt
  • Severe depression includes the following:
  • Hospitalization for depression,
  • Electro convulsive therapy for depression, or
  • Depression that resulted in a prolonged absence from work and/or significant disruption of daily functions.
  • Subjects with uncontrolled hypertension and/or diabetes.
  • Alcohol consumption >50 g/day.
  • Nonprescription injection drug use in past 6 months.
  • HIV antibody positive.
  • Previous Infliximab or other anti-TNF treatment, previous interferon; Pegylated interferon alfa-2b and ribavirin of any form.
  • Clinically significant impairment in cardiac or renal function, central nervous system, pulmonary, immunological, vascular and gastrointestinal disease.
  • Current malignancy (other than resected cutaneous basal, squamous cell carcinoma and/or in situ cervical cancer).
  • Use of illicit drugs which, in the investigator's opinion, may interfere with compliance with the study procedures.
  • Any other condition which, in the opinion of a physician, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study.
  • Have shown a previous immediate hypersensitivity response, including anaphylaxis, to an immunoglobulin product (plasma-derived or recombinant, e.g., monoclonal antibody).
  • Have a known allergy to murine proteins or other chimeric proteins.
  • Have or have had any of the following infections within 6 months of screening: herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB.
  • Have a transplanted organ (with the exception of a corneal transplant performed > 3 months prior to screening).
  • Have a concomitant diagnosis or any history of congestive heart failure (CHF).
  • History of noncompliance to medical regimens, or other condition/circumstance that could interfere with the patient's adherence to protocol requirements (e.g., psychiatric disease, lack of motivation, travel, etc).
  • Any cause of liver disease other than chronic hepatitis C, including but not limited to:
  • Hemochromatosis
  • Alpha-1 antitrypsin deficiency
  • Wilson's disease
  • Autoimmune hepatitis
  • Alcoholic liver disease
  • Non-alcoholic steatohepatitis (NASH)
  • Drug-related liver disease
  • Subject with a positive TST might be enrolled if the diagnosis of tuberculosis is ruled out. To rule out TB, the following criteria must be met:
  • The medical history is negative for symptoms of TB
  • The physical examination must reveal no observations that could be related to TB
  • The patient has a documented adequate course of treatment for either LTBI or TB at least 6 months prior to screening

About this study

Official title: Effect of Infliximab in Hepatitis-C Genotype 1 Naïve Patients With High TNF-alpha on the Efficacy of Pegylated Interferon Alfa-2b/Ribavirin Therapy

This is a Phase IIIB, randomized, prospective, multicenter, single-country, open-label, controlled pilot trial designed to evaluate the effect of infliximab induction therapy on sustained virologic response (SVR) to treatment with pegylated interferon alfa-2b plus ribavirin in a group of 96 therapy-naïve subjects with genotype 1 hepatitis C virus (HCV) infection and high serum tumor necrosis factor (TNF)-alpha values.

Being tested
Induction dose of (a) infliximab followed by combination of (b) pegylated interferon alfa-2b and (c) ribavirin, Combination of (a) pegylated interferon alfa-2b and (b) ribavirin
Keywords
pegylated interferon alfa-2b, ribavirin, infliximab, chronic hepatitis C
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.

  • Induction dose of (a) infliximab followed by combination of (b) pegylated interferon alfa-2b and (c) ribavirinDrug

    Also called (a) SCH 215596, Remicade, PEGETRON combination therapy, (b) SCH 54031, PEG-Intron, PegIntron, (c) SCH 18908, REBETOL

    1. Powder for intravenous infusion (100 mg strength), intravenous, single dose of 5 mg/kg, at Day -7, prior to initiation of the following combination therapy:
    2. powder for injection in vials or Redipen (80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
    3. 200 mg capsules, oral, dose of 800-1400 mg (weight based dosing as per PEGETRON Product Monograph), daily for up to 48 weeks

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

    Also called PEGETRON combination therapy, (a) SCH 54031, PEG-Intron; PegIntron, (b) SCH 18908, REBETOL

    1. Powder for injection in vials or Redipen (80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
    2. 200 mg capsules, oral, dose of 800-1400 mg (weight based dosing as per PEGETRON Product Monograph), daily for up to 48 weeks
Study groups in NCT00237484
Study groupRoleWhat they receive
Arm AExperimentalRemicade induction dose at Day -7 prior to initiation of PEGETRON treatment for up to 48 weeks
Receives: Drug: Induction dose of (a) infliximab followed by combination of (b) pegylated interferon alfa-2b and (c) ribavirin
Arm BActive comparatorPEGETRON treatment for up to 48 weeks
Receives: Drug: Combination of (a) pegylated interferon alfa-2b and (b) ribavirin

What is being measured

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

  1. Proportion of subjects who have achieved sustained virological response (SVR) in the infliximab (induction dose) plus PEGETRON and the PEGETRON groups at 24 weeks post treatment end

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

Secondary outcomes (2)

  1. Early virological response (EVR)

    Measured: Week 12 of PEGETRON treatment period

  2. Safety parameters

    Measured: During 48-week PEGETRON treatment period and 24-week follow up

Timeline

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

  1. First posted12 Oct 2005 (estimated)
  2. Study start18 Jul 2005
  3. Primary completion30 Jun 2011
  4. Study completion30 Jun 2011

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00237484
Sponsor's protocol ID
P04257
Acronym
Pegade
Status last verified
Aug 2020
First submitted
10 Oct 2005
Last updated
26 Aug 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Induction dose of (a) infliximab followed by combination of (b) pegylated interferon alfa-2b and (c) ribavirin and Combination of (a) pegylated interferon alfa-2b and (b) ribavirin in people with 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 20 inclusion and 41 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 26 Aug 2020. 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?

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?

Proportion of subjects who have achieved sustained virological response (SVR) in the infliximab (induction dose) plus PEGETRON and the PEGETRON groups at 24 weeks post treatment end (time frame: 24 weeks after completion of up to 48 weeks of PEGETRON 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 NCT00237484.

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 26 Aug 2020.

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