Trials Sponsors Conditions Drugs Pricing

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

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

Study Arms (3)

Early Responders (ER)

EXPERIMENTAL

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. 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).

Biological: Peginterferon alfa-2b (SCH 054031)Drug: Ribavirin (SCH 018908)

Slow Responders (SR): Decrease in viral load >=2 log

EXPERIMENTAL

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. 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).

Interventions

Peginterferon alfa-2b (SCH 054031)Biological

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.

Also known as: PegIntron

Early Responders (ER)Nonresponders (NR): Decrease in viral load <2 logSlow Responders (SR): Decrease in viral load >=2 log

Ribavirin (SCH 018908)

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients who had given their informed consent in writing.
Adult patients, older than 18 and younger than 65 years.

Sponsors & Collaborators

Schering-Plough
Industrylead

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2bRibavirin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver Diseases

Enrollment

103 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

July 25, 2008

First Posted

July 29, 2008

Study Start

June 2005

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

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
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.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Early Responders (ER)

Slow Responders (SR): Decrease in viral load >=2 log

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Nonresponders (NR): Decrease in viral load <2 log

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Early Responders (ER)

Slow Responders (SR): Decrease in viral load >=2 log

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Nonresponders (NR): Decrease in viral load <2 log

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record