Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C - Full Text View

Purpose

The purpose of this study is to determine the effectiveness, safety and tolerability of telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in treatment-naïve and treatment-experienced Russian patients with genotype 1 chronic hepatitis C.

Condition	Intervention	Phase
Genotype 1 Chronic Hepatitis C	Drug: Telaprevir Drug: Pegylated-interferon-alfa-2a Drug: Ribavirin	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open-Label, Bridging Study to Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Treatment- Naïve and Treatment-Experienced Russian Subjects With Genotype 1 Chronic Hepatitis C

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon Ribavirin Interferon Alfa-2a Peginterferon Alfa-2a Telaprevir Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Janssen-Cilag International NV:

Primary Outcome Measures:

Proportion of patients having undetectable plasma HCV ribonucleic acid (RNA) levels [ Time Frame: at Week 12 of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients having undetectable plasma HCV ribonucleic acid (RNA levels) [ Time Frame: at Week 4 of treatment ] [ Designated as safety issue: No ]
Proportion of patients having undetectable plasma HCV ribonucleic acid (RNA levels) [ Time Frame: at Week 12 of treatment ] [ Designated as safety issue: No ]
Proportion of patients having undetectable plasma HCV ribonucleic acid (RNA levels) [ Time Frame: at end of treatment (Week 24, Week 48 or early discontinuation) ] [ Designated as safety issue: No ]
Proportion of patients having undetectable plasma HCV ribonucleic acid (RNA levels) [ Time Frame: at Week 12 after the last planned dose of study drug (SVR12planned) ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	January 2012
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 12 weeks Telaprevir + 24 or 48 weeks PegIFN/RBV	Drug: Telaprevir Telaprevir Type = exact number, unit = mg, number = 750, form = tablet, route = oral. Telaprevir 750 mg (2 oral tablets) is taken every 8 hours for 12 weeks Drug: Pegylated-interferon-alfa-2a Pegylated-interferon-alfa-2a type = exact number, unit = microgram, number = 180, form = injection, route = subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Drug: Ribavirin Ribavirin Type = exact, number = 1000 or 1200, unit = mg, form = tablet, route = oral. 1000mg (if patient's weight is < 75kg) or 1200mg (if patient's weight is >= 75kg) per day.

Arms

Assigned Interventions

Experimental: 12 weeks Telaprevir + 24 or 48 weeks PegIFN/RBV

Drug: Telaprevir

Telaprevir Type = exact number, unit = mg, number = 750, form = tablet, route = oral.

Telaprevir 750 mg (2 oral tablets) is taken every 8 hours for 12 weeks

Drug: Pegylated-interferon-alfa-2a

Pegylated-interferon-alfa-2a type = exact number, unit = microgram, number = 180, form = injection, route = subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks

Drug: Ribavirin

Ribavirin Type = exact, number = 1000 or 1200, unit = mg, form = tablet, route = oral. 1000mg (if patient's weight is < 75kg) or 1200mg (if patient's weight is >= 75kg) per day.

Detailed Description:

This is an open-label (all persons know the study drug assignment), multicenter study in treatment-naïve (patient did not receive any previous treatment for the treatment of hepatitis C) and treatment-experienced (patient did receive previous treatment for hepatitis C) Russian patients with genotype 1 chronic hepatitis C. After a screening period of approximately 4 weeks, patients will be treated for 12 weeks with telaprevir 750 mg every 8 hours in combination with Peg-IFN-alfa-2a and RBV followed by 12 or 36 weeks of treatment with Peg-IFN-alfa-2a and RBV alone depending on their liver disease status, response to previous treatment and individual virologic response during treatment in this study. After the treatment period, there is a follow-up phase of at least 12 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient has genotype 1 chronic hepatitis C with HCV RNA level >1000 IU/mL
patient is either treatment-naïve and did not receive any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C, or patient is treatment-experienced who did not achieve sustained virologic response (SVR) 24 weeks after at least 1 prior course of Peg-IFN/RBV therapy (null-responder, partial-responder or viral relapse)
Patient must have documentation of liver biopsy or fibroscan within 2 years before the screening visit or agree to have a biopsy or fibroscan within the screening period unless histological cirrhosis was demonstrated by a biopsy or fibroscan > 2 years ago prior to screening
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:

Prior non-responder that is classified as a viral breakthrough patient
Patient is infected or co-infected with HCV of another genotype than genotype 1
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 or hepatocellular carcinoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498068

Locations

Russian Federation

Moscow, Russian Federation

Saint-Petersburg, Russian Federation

Samara, Russian Federation

Smolensk, Russian Federation

Stavropol, Russian Federation

Sponsors and Collaborators

Janssen-Cilag International NV

Investigators

Study Director:

Janssen-Cilag International NV, Belgium Clinical Trial

Janssen-Cilag International NV

More Information

No publications provided

Responsible Party:	Janssen-Cilag International NV
ClinicalTrials.gov Identifier:	NCT01498068 History of Changes
Other Study ID Numbers:	CR100676, VX-950HPC3007
Study First Received:	December 6, 2011
Last Updated:	May 6, 2013
Health Authority:	Russia: Ministry of Health of the Russian Federation

Keywords provided by Janssen-Cilag International NV:

Genotype 1 chronic Hepatitis C
VX-950HPC3007
VX-950

Hepatitis C
Telaprevir
HCV

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a

Interferons
Ribavirin
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites

ClinicalTrials.gov processed this record on May 16, 2013