Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection

Hepatitis C, Chronic Clinical Trial

Official title:

A Phase 2b, Multicenter, Randomized, Open-label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Different Treatment Regimens of AL-335, Odalasvir, and Simeprevir in Treatment-naive and Treatment-experienced Subjects With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5, and 6 Infection Without Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02765490
• Other study ID #: CR108070
• Secondary ID: 64294178HPC20012
• Status: Completed
• Phase: Phase 2
• Start date: November 9, 2016
• Est. completion date: November 16, 2017

Study information

• Verified date: November 2019
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected subjects without cirrhosis.

Description:

This is a Phase 2b multicenter study. The study will include a screening period of maximum 6 weeks, a treatment period of 6 or 8 weeks and a 24-weeks post-treatment follow-up period. The total study duration for each subject will be 36 to 38 weeks. This study investigates a 3 direct-acting antiviral agent (DAA) combination of AL-335 (HCV NS5B inhibitor), odalasvir (ODV) (a second generation HCV NS5A inhibitor) and simeprevir (SMV) (HCV NS3A4 protease inhibitor). The results of this study will enable the selection of treatment and duration to be further developed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: November 16, 2017
• Est. primary completion date: August 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Individuals with chronic hepatitis C virus (HCV) genotype 1, 2, 4, 5 or 6 infection

• Documented as treatment naive or experienced with a prior regimen consisting of Interferon (IFN) +/-Ribavirin (RBV) regimen without achieving sustained viral response

• Absence of cirrhosis

• Screening laboratory values within defined thresholds

• Must use specific contraceptive methods if female of childbearing potential or sexually active male

Exclusion Criteria:

• Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV)

• Prior exposure to an HCV direct-acting antiviral agent (DAA), either in combination with pegylated interferon (PegIFN) or IFN-free

• Current or prior history of clinical hepatic decompensation

• History of clinically significant illness or any other medical disorder including cardiovascular conditions that may interfere with individual's treatment, assessment or compliance with the protocol

• Pregnant or a nursing female

Related Conditions & MeSH terms

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

Intervention

Drug:
• AL-335
AL-335 800 mg (2*400) tablet will be administered once daily.
• Odalasvir
Odalasvir 25 mg tablet will be administered once daily.
• Simeprevir
Simeprevir 75 mg capsule will be administered once daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

Belgium,  Canada,  Germany,  Poland,  Singapore,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)	The SVR 12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 12 weeks after actual EOT.	Week 12 (Follow-Up Phase)
Secondary	Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Treatment (SVR24)	The SVR24 was defined as HCV RNA	Week 24 (Follow-Up Phase)
Secondary	Number of Participants With Viral Relapse	Viral Relapse: Participants who did not achieve SVR12, with HCV RNA	End of Treatment up to Week 24 (Follow up phase)
Secondary	Number of Participants With Late Viral Relapse	Late Viral Relapse: Participants who achieved SVR12 but had confirmed HCV RNA>=LLOQ afterwards during follow-up.	Up to Week 24 (Follow-up Phase)
Secondary	Percentage of Participants With On-treatment Failure	On-treatment failure: Participants who did not achieve SVR12 and with confirmed HCV RNA>=LLOQ at the End of Treatment (EOT).	EOT up to Week 12 (Follow up Phase)
Secondary	Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Treatment (EOT)	The SVR 4 was defined as participants were considered to have reached SVR4, if 4 weeks after the actual EOT, HCV RNA was	Week 4 (Follow-Up Phase)