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Hepatitis C, ChronicPhase 4NCT00724620

PEG-IFN Alfa-2b Plus Ribavirin for Treatment of Mexican naïve Patients With Chronic Hepatitis C Infected With Genotype 1 (Study P04511)(COMPLETED)

A Phase 4 study testing Peginterferon alfa-2b (SCH 054031) and Ribavirin (SCH 018908) in people with Hepatitis C, Chronic, run by Schering-Plough.

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 study aims to evaluate the efficacy and safety of peginterferon alfa-2b plus weight-based ribavirin as initial treatment in chronic hepatitis C virus (HCV) genotype 1 patients. All patients will receive peginterferon alfa-2b plus oral ribavirin for 12 weeks. 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?
Peginterferon alfa-2b (SCH 054031) and Ribavirin (SCH 018908)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
No sites listed yet
Study dates
Jun 2005to Feb 2008
Phase
Phase 4
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

  • Patients who had given their informed consent in writing.
  • Adult patients, older than 18 and younger than 65 years.
  • Be hepatitis C treatment-naïve patients.
  • Patients should have been assessed at entry and their METAVIR score of fibrosis determined as F2, F3 or F4.
  • Patients should have been diagnosed, at treatment week 0, visit 1 (V1), chronic hepatitis C determined through a positive HCV-RNA test by RT-PCR (reverse transcriptase-polymerase chain reaction) assay.
  • Patients with F4 METAVIR score should have a Class A score in Child-Pugh classification, in which the following criteria should be met: Prothrombin time <=3.0 seconds; Absence of ascites; Absence of encephalopathy.
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  • Patients should have a compensated liver disease meeting the following minimum hematologic, biochemical and serologic criteria: Hemoglobin: >=12 g/dL in women and >=13 g/dL in men; Leukocyte count: >=3 000/mm^3; Neutrophil count: >=1 500/mm^3; Platelet count: >=80 000/mm^3; Direct bilirubin, albumin, serum creatinine: within normal ranges.
  • Patients with a history of addiction should have abstained from consuming drugs for at least two years. All patients must be willing not to consume alcohol during the study.
  • The investigator should confirm that sexually active women in child-bearing age are using adequate contraceptive methods.
  • Neither the participating women nor the partners of participating men shall get pregnant during the study.
  • Women must not get pregnant or be breast-feeding during the study period.

Who cannot join

  • Having participated in any other clinical study within 30 days prior to visit at week 0 (V1) of this study treatment.
  • Suffering from another liver disease other than chronic hepatitis C, such as: Hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's disease, Autoimmune hepatitis , Alcoholic liver disease, Obesity-induced liver disease, Drug-induced liver disease.
  • With a known coinfection with HIV or HBV.
  • With evidence of decompensated liver diseases, such as history or presence of ascites, jaundice, bleeding varices, esophageal or gastric varices or hepatic encephalopathy.
  • With a history of hepatocellular carcinoma (HCC).
  • With any pre-existing medical condition that may interfere with patient's participation in and/or conclusion of the study, such as: Clinically significant retinal anomalies, Central nervous system (CNS) trauma or convulsive disorders, Poorly controlled diabetes mellitus, Autoimmune diseases (eg, inflammatory intestinal diseases [Crohn's disease, ulcerative colitis], rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical cryoglobulinemia with vasculitis, or symptomatic thyroid disorders), Chronic pneumopathies (eg, chronic obstructive pulmonary disease), Cardiovascular dysfunction or clinically significant electrocardiographic alterations within six months prior to visit at week 0 (eg, angina pectoris, congestive heart failure, recent heart attack, severe hypertension or significant arrhythmia), Suspected hypersensitivity to any interferon or to Ribavirin, Any organ transplantation, except corneal and hair transplantation
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  • With signs of suspected or active cancer or history of cancer within past five years (except for basocellular skin carcinomas receiving adequate treatment)
  • With addiction, such as alcoholism (>=40 g/day), intravenous (IV) drugs and inhaled drugs. Patients who have received methadone, buprenorphine hydrochloride or butorphanol tartrate within past two years may not be admitted either.
  • Suffering from any other condition that, in the investigator's opinion, would either make the patient inadequate for admission to study or affect his/her participation in and the conclusion of the study.

About this study

Official title: Open Multicenter Study of Combination Therapy With Weight-Based PEG-IFN Alfa-2b Plus Ribavirin for Treatment of Mexican naïve Patients With Chronic Hepatitis C Infected With Genotype 1. Impact of the Combination Therapy on Sustained Virological Response and Tolerability, in These Patients.

This study aims to evaluate the efficacy and safety of peginterferon alfa-2b plus weight-based ribavirin as initial treatment in chronic hepatitis C virus (HCV) genotype 1 patients. All patients will receive peginterferon alfa-2b plus oral ribavirin for 12 weeks. At the end of this period, quantitative PCR will be used to determine the Early Viral Response (EVR) at this point of treatment. Total treatment duration will be 48 weeks for Early Responders, 72 weeks for Slow Responders, and 12 weeks for Nonresponders.

Being tested
Peginterferon alfa-2b (SCH 054031), Ribavirin (SCH 018908)
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.

  • Peginterferon alfa-2b (SCH 054031)Biological

    Also called PegIntron

    All patients will receive peginterferon alfa-2b 1.5 ug/kg administered subcutaneously (SC) once weekly in combination with ribavirin (800-1200 mg/day) administered orally (PO) for a minimum period of 12 weeks. The total treatment duration will be as follows: 48 weeks for Early Responders, 72 weeks for Slow Responders, and 12 weeks for Nonresponders.

  • Ribavirin (SCH 018908)Drug

    Also called Rebetol

    All patients will receive peginterferon alfa-2b 1.5 ug/kg administered subcutaneously (SC) once weekly in combination with ribavirin (800-1200 mg/day) administered orally (PO) for a minimum period of 12 weeks. The total treatment duration will be as follows: 48 weeks for Early Responders, 72 weeks for Slow Responders, and 12 weeks for Nonresponders.

Study groups in NCT00724620
Study groupRoleWhat they receive
Early Responders (ER)ExperimentalAll patients will receive peginterferon alfa-2b 1.5 ug/kg administered subcutaneously (SC) once weekly in combination with ribavirin (800-1200 mg/day) administered orally (PO) for a minimum period of 12 weeks. Patients who have responded to therapy at Treatment Week 12 (ie, who are Early Responders defined by HCV-RNA[-] at Treatment Week 12) will continue the combined treatment for a total of 48 weeks and will complete 24 weeks of follow up to determine the Sustained Viral Response (SVR).
Receives: Biological: Peginterferon alfa-2b (SCH 054031); Drug: Ribavirin (SCH 018908)
Slow Responders (SR): Decrease in viral load >=2 logExperimentalAll patients will receive peginterferon alfa-2b 1.5 ug/kg administered subcutaneously (SC) once weekly in combination with ribavirin (800-1200 mg/day) administered orally (PO) for a minimum period of 12 weeks. Patients who have a slow response to therapy at Treatment Week 12 (ie, Slow Responders who are not HCV-RNA[-] at Treatment Week 12 but decrease >=2 log) will continue the combined treatment for a total of 72 weeks and will complete 24 weeks of follow up to determine the Sustained Viral Response (SVR).
Receives: Biological: Peginterferon alfa-2b (SCH 054031); Drug: Ribavirin (SCH 018908)
Nonresponders (NR): Decrease in viral load <2 logExperimentalAll patients will receive peginterferon alfa-2b 1.5 ug/kg administered subcutaneously (SC) once weekly in combination with ribavirin (800-1200 mg/day) administered orally (PO) for a minimum period of 12 weeks. Patients who have not responded to therapy at Treatment Week 12 (ie, Nonresponders who are not HCV-RNA[-] at Week 12 of Treatment and/or have a decrease in viral load <2 log) will stop treatment at Treatment Week 12.
Receives: Biological: Peginterferon alfa-2b (SCH 054031); Drug: Ribavirin (SCH 018908)

What is being measured

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

  1. To evaluate the overall SVR of chronic hepatitis C Genotype 1 Naïve Mexican patients with different durations of treatment.

    Measured: SVR will be determined after 48 weeks of treatment and 24 weeks of follow-up in the Early Responders and after 72 weeks of treatment and 24 weeks of follow-up in the Slow Responders.

Timeline

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

  1. First posted29 Jul 2008 (estimated)
  2. Study startJun 2005
  3. Primary completionFeb 2008
  4. Study completionFeb 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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00724620
Sponsor's protocol ID
P04511
Status last verified
Jul 2008
First submitted
25 Jul 2008
Last updated
29 Jul 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Peginterferon alfa-2b (SCH 054031) and Ribavirin (SCH 018908) in people with Hepatitis C, Chronic, run by Schering-Plough.

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 11 inclusion and 9 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 29 Jul 2008. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

To evaluate the overall SVR of chronic hepatitis C Genotype 1 Naïve Mexican patients with different durations of treatment. (time frame: SVR will be determined after 48 weeks of treatment and 24 weeks of follow-up in the Early Responders and after 72 weeks of treatment and 24 weeks of follow-up in the Slow Responders.). 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 NCT00724620.

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 29 Jul 2008.

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