A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

NCT01447420 | Completed Phase 4 Results

• 1 other identifier: ML25592
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 15

Brief Summary

This multi-center, open-label study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated time of study treatment is 48 weeks, follow-up is 24 weeks.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression

  Participants with sustained virological response (SVR) rate in relation to interleukin 28B expression were reported. SVR rate is defined as the percentage of participants with undetectable HCV Ribonucleic acid (RNA), measured at least 24 weeks after the end of treatment (48 weeks) in terms of the expression profile of Interleukin 28B (IL-28B) (CC, CT or TT) in participants with genotype 1 hepatitis C virus (HCV) chronic infection. Participants with detectable HCV RNA or without measurement at the end of the follow-up period were considered as non-responders.

  At Week 72

• Percentage of Participants With Incidence of Anemia

  Anemia is a condition marked by a deficiency of red blood cells (RBCs) or of hemoglobin (Hb) in the blood, resulting in pallor and weariness anemia (Hb \< 11 gram per decilitre (g/dL) for women and Hb \< 12 g/dL for men). Incidence of anemia was calculated by dividing the number of participants who experienced the event by the number of participants in the safety population.

  Up to Week 72

Secondary Outcomes (3)

• Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression

  Weeks 4, 12, 24, 48, 60 and 72

• Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment

  Up to Week 72

• Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12

  From Baseline (Week 0) to Week 12

Study Arms (1)

Peginterferon Alfa-2a Plus Ribavirin

EXPERIMENTAL

Drug: peginterferon alfa-2a; Drug: ribavirin [Copegus]

Interventions

peginterferon alfa-2a DRUG

180 mcg sc weekly, 48 weeks

Peginterferon Alfa-2a Plus Ribavirin

ribavirin [Copegus] DRUG

1'000 or 1'200 mg orally daily, 48 weeks

Peginterferon Alfa-2a Plus Ribavirin

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, \>/=18 and \<70 years of age at initiation of treatment
• Body weight between 50 kg and 125 kg at baseline
• Chronic hepatitis C, genotype 1
• Chronic liver disease consistent with HCV infection
• Compensated liver disease (Child-Pugh Grade A)

You may not qualify if:

• Pregnant or lactating women, and male partners of pregnant women
• Chronic hepatitis C, genotype 2, 3, 4, 5 or 6
• Previous treatment with interferon or ribavirin
• Positive for hepatitis A, hepatitis B or HIV infection
• History or evidence of a medical condition associated with liver disease other than chronic hepatitis C
• Decompensated liver disease and/or liver disease Child-Pugh classification \>6
• Hepatocellular carcinoma
• History or evidence of esophageal bleeding
• Hemoglobinopathy, or any other cause for possible hemolysis
• Hb \<11 g/dL in women, \<12 g/L in males

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (15)

Unknown Facility

Vitória, Espírito Santo, 29043-260, Brazil

Location

Unknown Facility

Salvador, Estado de Bahia, 41110-170, Brazil

Location

Unknown Facility

Juiz de Fora, Minas Gerais, 36038-330, Brazil

Location

Unknown Facility

Rio de Janeiro, Rio de Janeiro, 20020-022, Brazil

Location

Unknown Facility

Rio de Janeiro, Rio de Janeiro, 20270-004, Brazil

Location

Unknown Facility

Joinville, Santa Catarina, 89202-050, Brazil

Location

Unknown Facility

Sao Jose Do Rio Preto, Santa Catarina, 15090-000, Brazil

Location

Unknown Facility

Botucatu, São Paulo, 18600-400, Brazil

Location

Unknown Facility

Campinas, São Paulo, 13026-210, Brazil

Location

Unknown Facility

Campinas, São Paulo, 13060-803, Brazil

Location

Unknown Facility

Santos, São Paulo, 11015470, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 04040-003, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 04119-001, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 04266-010, Brazil

Location

Unknown Facility

Sorocaba, São Paulo, 18047-600, Brazil

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 616878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 6, 2011
• Study Start: February 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 25, 2016
• Results First Posted: June 24, 2016

Record last verified: 2016-06

Locations

BR (15)