VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection

Genotype 1 Chronic Hepatitis C Clinical Trial

Official title:

A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241760
• Other study ID #: CR013711
• Secondary ID: OPTIMIZE-HCVVX-9
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2010
• Last updated: May 14, 2014
• Start date: December 2010
• Est. completion date: November 2012

Study information

• Verified date: May 2014
• Source: Janssen Infectious Diseases BVBA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUSA: FOOD AND DRUG ADMINISTRATION - CENTER FOR DRUG EVALUATION AND RESEARCHGermany: Ethics CommissionGreat Britain: Medicines and Healthcare Products Regulatory AgencyIreland: Irish Medicines Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.

Description:

This is a randomized (study drug assigned by chance), open-label (all persons know the study drug assignment) multicenter study to evaluate the effectiveness of telaprevir administered orally as 1125 milligram (mg) twice daily versus 750mg every 8 hours in combination with Peg-IFN-alfa-2a, administered via intramuscular injection once a week, and ribavirin, administered as an oral tablet twice a day, in treatment-naïve study participants with chronic hepatitis C virus (HCV) genotype 1 infection.

Telaprevir will be given orally (by mouth) from Day 1 through Week 12 as 3 tablets (1125mg) twice daily or 2 tablets (750mg) every 8 hours. Peg-IFN-alfa-2a will be administered once a week as an injection under the skin (180 microgram/week) from Day 1 through Week 24 or 48 (based on the patient's treatment response on week 4). Ribavirin is administered orally (by mouth) twice daily from Day 1 through Week 24 or 48 (based on the participant's treatment response on week 4) as 1,000-1,200 mg per day. After the end of treatment (Week 24, Week 48, or at early discontinuation of all study drugs), participants with undetectable HCV RNA at end of treatment will be required to attend follow-up visits until Week 72 safety/tolerability assessments will be performed throughout the treatment period and during the follow-up period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 744
• Est. completion date: November 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patient has chronic HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL

• Patients should not have had any previous treatment for hepatitis C

• Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period

• Patients with cirrhosis should have serum alpha-fetoprotein (AFP) <= 50 ng/mL. If AFP > 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period

• A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV.

Exclusion Criteria:

• Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype

• Patient has a pre-existing psychiatric condition

• Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C

• Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection

• Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).

Study Design

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

Related Conditions & MeSH terms

• Genotype 1 Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Treatment Naive
• Virus Diseases

Intervention

Drug:
• Ribavirin
Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
• Telaprevir
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
• Pegylated interferon alfa-2a
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
• Telaprevir
750 mg (2 oral tablets) every 8 hours for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Janssen Infectious Diseases BVBA	Vertex Pharmaceuticals Incorporated

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  France,  Germany,  Ireland,  Mexico,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)	The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned). SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).	End of trial, 12 weeks after last planned dose	No
Secondary	Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)	The table below shows the percentage of participants achieving SVR 24 weeks after the last planned dose of study medication. SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL). The response for T12(b.i.d)/PR group is higher than that after 12 weeks because HCV RNA data for two participants were missing for SVR assessment at that time. Consequently, by definition of SVR12, they were counted as not having achieved SVR12.	End of trial, 24 weeks after last planned dose	No
Secondary	Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)	The table below shows the percentage of participants achieving SVR 72 weeks after the start of study medication (SVR72 planned). SVR was defined as having plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 IU/mL, target not detected, at end of treatment and up to 72 weeks after start of study medication (i.e., no confirmed detectable HCV RNA in between).	End of trial, 72 weeks after the start of study medication	No
Secondary	Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.	The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, which means less than 25 IU/ml, target not detected, at different time points during the study.	Baseline, Week 4 and Week 4+12.	No
Secondary	Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs	The table below shows the percentage of participants who met a stopping rule, defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value at Week 4 >1000 IU/mL and at Weeks 12, 24, 32 and 40 =25 IU/mL.	Week 4, 12, 24, 32, 40	No
Secondary	Percentage of Participants Who Relapsed During Follow-up Period	The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 12-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).	During Follow-Up (24 weeks after the last dose of study drug)	No
Secondary	Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)	The table below shows the effect of interleukin 28B (IL28B) gene's subtype (CC, CT or TT genotype) on the primary outcome measure: SVR12 planned.	End of trial, 12 weeks after the last planned dose	No