AzTrials
AzTrials

Hepatitis C, ChronicPhase 3NCT00265395

Extended Treatment With PEG-Intron® and Rebetol® in Patients With Genotype 1 Chronic Hepatitis C and Slow Virologic Response (Study P03685)

A Phase 3 study testing Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®) and Combination of pegylated interferon alfa-2b and 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
Search all trials

Trial summary

This is a controlled, randomized, parallel-groups, open-label, multinational study designed to evaluate the efficacy and safety of PEG-Intron® (pegylated interferon alfa-2b) plus Rebetol® (ribavirin) in subjects with chronic hepatitis C. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®) and Combination of pegylated interferon alfa-2b and ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,428 participants
Where
No sites listed yet
Study dates
Dec 2004to May 2008
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

  • Adult subjects aged 18 to 70 years, of either sex.
  • Genotype-1 hepatitis C virus (HCV)-ribonucleic acid (RNA)-positive subjects.
  • Subjects must be willing to give written informed consent and able to adhere to dosing and visit schedules.
  • Confirmation of liver biopsy availability: Availability of a liver biopsy performed within 18 months prior to the Screen visit, with a pathology report confirming the histological diagnosis of chronic hepatitis or liver cirrhosis.
  • Compensated liver disease with the following minimum hematological, biochemical, and serological criteria at the screen visit (WNL = within normal limits, ULN = Upper Limit Normal):
  • Hemoglobin values of equal or more than 12 g/dL for females and 13 g/dL for males.
Show all 24Show fewer
  • White blood cells (WBCs) 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
  • Direct bilirubin up to 10% above ULN is acceptable.
  • Indirect bilirubin up to 10% above ULN is acceptable (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 3.0 mg/dL (less than or equal to 51.3 µmol/L)
  • Albumin up to 10% above ULN is acceptable.
  • Serum creatinine up to 10% above ULN is acceptable.
  • Alanine aminotransferase (ALT) level above ULN at Screen.
  • At the Screen Visit, fasting glucose must be 70-140 mg/dL. Results between 116-140 mg/dL require repeat fasting glucose to be less than 140 mg/dL and HbA1C less than or equal to 8.5%. HbA1C must be less than or equal to 8.5% in diabetic subjects (whether on medication or diet controlled).
  • Antinuclear antibodies (ANA) must be less than or equal to 1:320.
  • Thyroid Stimulating Hormone (TSH) WNL whether in euthyroid subjects or subjects requiring medical treatment. (subjects requiring medication to maintain TSH levels within normal limits are eligible if all other inclusion/exclusion criteria are met).
  • Confirmation by the principal investigator or a sub-investigator that sexually active females of childbearing potential are practicing adequate contraception.
  • Female subjects cannot be pregnant or breastfeeding and must be either postmenopausal, surgically sterile or using 2 methods of birth control. While abstinence from sexual activity is the only certain method to prevent pregnancy, female patients of childbearing potential who are or who anticipate the possibility of becoming sexually active with a male partner must use a combination of the following 2 methods :
  • Contraceptive pill or intrauterine device (IUD) or depot hormonal preparation (ring, injection implant) and
  • A barrier method of contraception such as diaphragm, sponge with spermicide, condom, or a method of birth control considered acceptable by the study physician. 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.
  • A serum pregnancy test obtained at Screen Visit prior to the initiation of treatment must be negative.
  • Confirmation by the principal investigator or a sub-investigator that sexually active male subjects are practicing a method of contraception considered acceptable (vasectomy, condom plus spermicide, plus relationship with a female partner who practices an acceptable method of contraception). Contraception must be used during the treatment period and for seven months (or 6 months, according to local label) after the completion of therapy, including condom use by male subjects with pregnant partners.
  • For subjects with a history of hypertension or diabetes, written clearance from an ophthalmologist has to be obtained prior to treatment start.

Who cannot join

  • Pregnant women, women who plan to become pregnant, male subjects whose partner wants to become pregnant, and breastfeeding women.
  • Previous treatment for chronic hepatitis C with an antiviral or immunomodulating agent or with some interferon or ribavirin product, whether alone or in combination.
  • Subjects weighing over 125 kg.
  • Suspected hypersensitivity to any interferon or ribavirin product.
  • Participation in other clinical trial within 30 days prior to screen into this study.
  • Coinfection with hepatitis B virus (HBV), human immunodeficiency virus (HIV), or both.
Show all 36Show fewer
  • 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
  • Active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma).
  • Known coagulation diseases such as hemophilia; hemoglobin diseases (e.g. thalassemia).
  • Known glucose 6-phosphate dehydrogenase (G6PD) deficiency
  • Evidence of advanced liver disease such as history or presence of ascites, bleeding varices, or hepatic encephalopathy.
  • Subjects with organ transplants, except for corneal or hair transplant.
  • Any known preexisting medical condition that could interfere with the subject's participation in and completion of study, such as:
  • Preexisting psychiatric condition, especially moderate to severe depression, or a history of severe psychiatric disorder, such as psychosis, suicidal ideation, or suicide attempts. Severe depression includes the following:
  • Hospitalization for depression
  • Electroconvulsive therapy for depression, or
  • Depression causing a prolonged absence from work or significantly altering daily functions.
  • Subjects with mild depression may be considered for entry into the study provided that a pre-treatment assessment demonstrates that the subject's emotional status is clinically stable, in which case a management plan must be formulated for the subject; this management plan will become a part of the subject's medical record.
  • Craniocerebral trauma which is not a concussion, or active seizure disorders requiring medication.
  • Clinically significant electrocardiogram (ECG) abnormalities and/or cardiovascular dysfunction within 6 previous months (e.g., angina, congestive heart failure, recent myocardial infarction, or significant arrhythmia).
  • Chronic lung disease (e.g., chronic obstructive lung disease)
  • Poorly controlled diabetes mellitus
  • Immune-mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis)
  • Clinical gout
  • Subject is or was a substance abuser, such as alcohol (80 g/day or more), methadone, intravenous(IV), oral or inhaled drugs. To be considered for inclusion into the protocol, the subject must have abstained and agree to abstain from using any of the above for at least 6 months. Subjects treated with buprenorphine (Subutex) who have been stable for 6 months may be included.
  • Cirrhotic subjects whose ultrasound confirms hepatocellular carcinoma.
  • Any other condition that, in the investigator's opinion, could determine that subject's participation in the study is not indicated or could interfere with the subject's participation in and completion of study.
  • Subjacent disease that potentially would require systematic administration of steroids
  • Insulin dependent diabetes mellitus

About this study

Official title: A Study to Assess Treatment With PEG-Intron® and Rebetol® in Naïve Patients With Genotype 1 Chronic Hepatitis C and Slow Virological Response

This is a controlled, randomized, parallel-groups, open-label, multinational study designed to evaluate the efficacy and safety of PEG-Intron® (pegylated interferon alfa-2b) plus Rebetol® (ribavirin) in subjects with chronic hepatitis C. It is designed to evaluate whether 72 weeks of treatment with PEG-Intron plus Rebetol is more effective than 48 weeks of treatment in subjects with Genotype 1 chronic hepatitis C who exhibit a slow response to treatment.

Being tested
Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®), Combination of pegylated interferon alfa-2b and ribavirin
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.

  • Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®)Drug

    Also called (a) SCH 54031; PEG-Intron; PegIntron; ViraferonPeg., (b) SCH 18908; Rebetol; REBETOL.

    1. Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for 48 weeks
    2. 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 48 weeks

  • Combination of pegylated interferon alfa-2b and ribavirinDrug

    Also called (a) SCH 54031; PEG-Intron; PegIntron; ViraferonPeg., (b) SCH 18908; Rebetol; REBETOL.

    1. Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strength), subcutaneous, dose of 1.5 micrograms/kg, weekly for 72 weeks.
    2. 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 72 weeks
Study groups in NCT00265395
Study groupRoleWhat they receive
Standard therapyActive comparatorSlow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
Receives: Drug: Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®)
Extended therapyExperimentalSlow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.
Receives: Drug: Combination of pegylated interferon alfa-2b and ribavirin

What is being measured

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

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

    LLQ = 30 IU/mL by reverse transcription polymerase chain reaction (RT-PCR) (Taqman Roche)

    Measured: 48 or 72 weeks of treatment plus 24 weeks of 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 posted14 Dec 2005 (estimated)
  2. Study startDec 2004
  3. Primary completionMay 2008
  4. Study completionMay 2008

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
1,428 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00265395
Sponsor's protocol ID
P03685
Other IDs
SUCCESS
Status last verified
Mar 2017
First submitted
13 Dec 2005
Last updated
5 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

  • Buti M, Lurie Y, Zakharova NG, Blokhina NP, Horban A, Teuber G, Sarrazin C, Balciuniene L, Feinman SV, Faruqi R, Pedicone LD, Esteban R; SUCCESS Study Investigators. Randomized trial of peginterferon alfa-2b and ribavirin for 48 or 72 weeks in patients with hepatitis C virus genotype 1 and slow virologic response. Hepatology. 2010 Oct;52(4):1201-7. doi: 10.1002/hep.23816.

    PubMed 20683847

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®) and Combination of pegylated interferon alfa-2b and 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 24 inclusion and 36 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 5 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 8 Jul 2009). 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?

Sustained Virologic Response, Defined as a Plasma HCV-RNA (Hepatitis C Ribonucleic Acid) Level Below the LLQ (Lower Level of Quantitation) at 24 Weeks Post-treatment. (time frame: 48 or 72 weeks of treatment plus 24 weeks of follow-up.). 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 NCT00265395, 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 5 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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