An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants

Chronic Hepatitis C Clinical Trial

Official title:

A Phase IIa Randomized, Open-Label Study of Telaprevir (VX-950) Administered Every 12 or Every 8 Hours in Combination With Either Peg-IFN alfa2a (Pegasys) and Ribavirin (Copegus) or Peg-IFN alfa2b (PegIntron) and Ribavirin (Rebetol) in Treatment-Naive Subjects With Chronic Genotype 1 Hepatitis C Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528528
• Other study ID #: CR013516
• Secondary ID: VX-950-TIDP24-C2
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2007
• Last updated: June 13, 2014
• Start date: October 2007
• Est. completion date: August 2009

Study information

• Verified date: June 2014
• Source: Tibotec BVBA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Bundesministerium für GesundheitBelgium: Ministerie van Volksgezondheid - Directoraat Generaal Bescherming Volksgezondheid: geneesmiddelenFrance: Agence Française de Sécurité Sanitaire des Produits de SantéGermany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) / Federal Institute for Drugs and Medical DevicesItaly: Agenzia Italiana del FarmacoNetherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO)Spain: Ministerio de Sanidad y Consumo - Agencia Espanola de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic (lasting a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.

Description:

This is a Phase 2a, open-label (all people know the identity of the intervention), multicenter trial (conducted in more than one center) in participants with chronic genotype 1 HCV infection. The trial consists of a Screening phase of approximately 4 weeks, a treatment phase up to 48 weeks depending on participants' individual virologic response, and a follow-up phase of at least 24 weeks. All participants will receive 12 weeks of telaprevir treatment in combination with standard therapy. At Week 12, telaprevir dosing will end and participants will continue on standard therapy only. Participants will be randomly assigned to receive one of the two different dosage regimens of telaprevir (750 milligram [mg] every 8 hours (hr), or 1125 mg every 12 hr) in combination with standard therapy (pegylated interferon [Peg-IFN]-alfa-2a and ribavirin [RBV] or Peg-IFN-alfa-2b and RBV at the standard doses). Efficacy will be evaluated by HCV Ribonucleic Acid (RNA) values, viral response, viral breakthrough, partial response, early viral kinetics and sustained viral response. Pharmacokinetics, Pharmacokinetic-pharmacodynamic relationship will also be evaluated. Safety will be monitored throughout the study duration.

Other known NCT identifiers

• NCT00614497

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Chronic genotype 1 Hepatitis (inflammation of the liver) C infection

• Never been treated for Hepatitis C Viral (HCV) infection

• No clinically significant lab abnormalities

• Amount of HCV Ribonucleic acid (RNA) in the blood more than 10,000 international units/milliliter (IU/mL) at entry

• Liver biopsy or "Fibroscan" test performed during screening or in the past 3 years

Exclusion Criteria:

• Contra-indications for starting anti-HCV therapy

• History or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease

• Any evidence of significant liver disease in addition to Hepatitis C

• Infected with Human Immunodeficiency Virus (a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person) or Hepatitis B

• Women who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding or the partner of a woman who is pregnant or breastfeeding

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Telaprevir
Oval tablets containing 375 mg of telaprevir for oral administration.
• Peg-IFN-alfa-2a
Solution containing Peg-IFN alfa2a for subcutaneous injection in a pre-filled syringe.
• Peg-IFN-alfa-2b
Powder containing Peg-IFN-alfa-2b and solvent for solution for subcutaneous injection in a pre-filled pen.
• Ribavirin (RBV) tablet
Tablets containing 200 mg RBV for oral administration.
• Ribavirin (RBV) capsule
Capsules containing 200 mg RBV for oral administration.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tibotec BVBA

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Virologic Response at Week 12	Virologic response was either defined as having undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 international units/milliliter (IU/mL) HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).	End of treatment (EOT) (up to Week 48)	No
Secondary	Time to First Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level	Virologic response was either defined as having undetectable HCV RNA (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).	Baseline (Day 1) up to EOT (up to Week 48)	No
Secondary	Number of Participants With Viral Breakthrough at End of Treatment (EOT)	Viral breakthrough was defined as a confirmed increase of more than 1 log 10 in HCV RNA level from the lowest level reached or a confirmed value of HCV RNA more than 100 IU/mL in participants whose HCV RNA was previously less than 25 IU/mL.	EOT (up to Week 48)	No
Secondary	Percentage of Participants With Partial Response	Partial response was defined as having at least 2 log drop in HCV RNA from Baseline, but not having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants' plasma samples).	Baseline (Day 1) up to EOT (up to Week 48)	No
Secondary	Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Week 12	Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology. HCV RNA samples were taken pre-dose of Peg-IFN administration.	Baseline (pre-dose), Week 12	No
Secondary	Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at End of Treatment (EOT)	Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology.	Baseline (pre-dose), EOT (up to Week 48)	No
Secondary	Percentage of Participants With Sustained Viral Response 24 Weeks After End of Treatment (SVR24)	SVR24 was defined as having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants' plasma samples) at EOT and no confirmed detectable HCV RNA levels between EOT and 24 weeks after the last dose of study medication.	EOT (up to Week 48) and up to 24 weeks after EOT	No