ACCELERATE Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC) Infection.

Hepatitis C, Chronic Clinical Trial

Official title:

A Randomized, Open-label Study of the Effect of PEGASYS and Ribavirin Combination Therapy on Sustained Virologic Response in Interferon-naïve Patients With Chronic Hepatitis C Genotype 2 or 3 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00077636
• Other study ID #: NV17317
• Status: Completed
• Phase: Phase 4
• First received: February 10, 2004
• Last updated: January 22, 2016
• Start date: December 2003
• Est. completion date: March 2006

Study information

• Verified date: January 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1469
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients >=18 years of age;

• CHC infection (genotype 2 or 3);

• liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;

• use of 2 forms of contraception during study and 6 months after the study in both men and women.

Exclusion Criteria:

• women who are pregnant or breastfeeding;

• male partners of women who are pregnant;

• conditions associated with decompensated liver disease;

• other forms of liver disease, including liver cancer;

• human immunodeficiency virus infection;

• previous treatment with an IFN, pegylated IFN, ribavirin, viramidine, levovirin, or amantadine.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Copegus
400mg po bid for 16 weeks
• Copegus
400mg po bid for 24 weeks
• peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 16 weeks
• peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  New Zealand,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virological Response (SVR)	SVR was defined as the percentage of participants with undetectable HCV RNA at 24 weeks after the completion of the study treatment. The negative assessment was required to be the last one collected at or after week 36 (ie, on or after study Day 253) for the 16-week treatment group or at or after week 44 (ie, on or after study Day 309) for the 24-week treatment group.	Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)	No
Secondary	Percentage of Participants With Virological Response at The End of Study Treatment	Virological response was defined as the percentage of participants with undetectable HCV RNA at the completion of the study treatment. The negative assessment was required to be the last one collected in the Week 16 time window for the 16-week treatment group or in the Week 24 time window for the 24-week treatment group.	Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group)	No
Secondary	Percentage of Participants Virological Response 12 Weeks Post-Treatment	Virological response 12 weeks post-treatment was defined as the percentage of participants with undetectable HCV RNA 12 weeks after the completion of the study treatment . The negative assessment was required to be the last one collected in the week 28 time window for the 16- week treatment group or in the week 36 time window for the 24-week treatment group.	Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group)	No
Secondary	Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An adverse event was defined as any untoward medical occurrence that occurred during he course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.	Up to Week 40 and Week 48	No
Secondary	Percentage of Participants With Marked Laboratory Abnormalities	Participants with changes in Hematocrit: Fraction 0.36 - 0.60 g/dL, Hemoglobin: 11.0 -20.0 g/dL, WBC 3.0 - 18.0 g/dL, Platelets 100 - 700 g/dL, Basophils 0.00 - 0.30 g/dL, Lymphocytes 1.00 - 6.30 g/dL, Monocytes 0.08 - 2.00 g/dL, Neutrophils 1.50 or more g/dL, Eosinophils 0.00 - 1.50 g/dL , PTT 0 - 50 seconds, Alkaline Phosphatase 0 - 190 and ASAT 0 - 50 U/L, ALAT 0 - 60 U/L, Gamma - GT 0 - 120 U/L, Total Protein 55 - 87 g/L ;Albumin 27.0 or more g/L, Total Bilirubin 0 - 34.2 µmol/L, BUN 0 - 14.3 mmol/L, Creatinine 0 - 154 µmol/L, Free T3, T4 5 - 40 pmol/L, TSH 0.0 - 10.0 mU/L, Cholesterol 0.0 - 8.3 mmol/L; Triglycerides 0.00 - 2.83 mmol/L, Chloride 95 - 115 mmol/L; Potassium 3.0 - 6.0 mmol/L; Sodium 130 - 150 mmol/L, miscellaneous: Calcium 2.00 - 2.90 mmol/L; Phosphate 0.75 - 1.60 mmol/L; Blood Glucose (Random) 2.80 - 11.10 mmol/L, Uric Acid 0 - 600 µmol/L, Proteinuria, Glycosuria, Hematuria (Qualitative 0 to 4+) 0 - 1 were analysed for the laboratory abnormality.	Up to Week 40 and Week 48	No
Secondary	Participants With Marked Abnormal Vital Signs	Participants with changes in Systolic and diastolic blood pressure, heart rate were analysed abnormal vital signs.	Up to Week 40 and Week 48	No
Secondary	Number of Participants With Highest Triglyceride Level	Participants with triglyceride level above normal (i.e. < 200 mg/dL) were analysed.	Up to Week 40 and Week 48	No