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A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir

A Phase 2a, Open-Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335 and Odalasvir, With or Without Simeprevir, in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Infection With or Without Compensated Child Pugh A Cirrhosis

NCT02569710•Alios Biopharma Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and tolerability of AL-335 in combination with odalasvir (ODV) with or without simeprevir (SMV) in participants with genotype (GT)1 or GT2 or GT3 chronic hepatitis C (CHC) infection.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participant has provided written consent
•2. In the Investigator's opinion, the participant is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned
•3. Male or female, 18-70 years of age
•4. Body mass index (BMI) 18-35 kilogram per meter square (kg/m\^2), inclusive
•5. A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin) pregnancy test at screening
•6. Female participants must either:
•* not be of childbearing potential defined as: i. Postmenopausal for at least 12 months (that is \[i.e.\], 2 years of amenorrhea without an alternative medical cause) and a serum follicle stimulating hormone (FSH) level in the postmenopausal range (per reference laboratory), OR ii. Surgically sterile (example \[e.g.\], underwent total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/bilateral tubal clips without reversal operation), or otherwise incapable of becoming pregnant, OR
•* be of childbearing potential AND
•* not heterosexually active (e.g., abstinent or homosexual) from screening until 6 months after study drug administration (or longer, if dictated by local regulations), OR
•* if heterosexually active
+23 more criteria

Exclusion Criteria

•1. Pregnant, planning on becoming pregnant (during treatment and up to 6 months after the end of treatment \[EOT\]), or breast-feeding female participant, or male participant whose female partner is pregnant or planning on becoming pregnant (during treatment and up to 6 months after the EOT)
•2. Other than CHC with or without compensated cirrhosis, clinically significant cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, thyroid or any other medical illness or psychiatric disorder, as determined by the Investigator and/or Sponsor's Medical Monitor
•3. History or other clinical evidence of significant or unstable cardiac disease (e.g., angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, and/or clinically significant ECG abnormalities), moderate to severe valvular disease or uncontrolled hypertension at screening
•4. Screening echocardiogram ejection fraction \<55 percentage (%) or any other echocardiographic finding suggestive of clinically relevant cardiomyopathy
•5. Creatinine clearance of \<60 mL/min (Cockcroft-Gault)
•6. Positive test for Hepatitis A virus immunoglobulin (HAV) Immunoglobulin M (IgM), Hepatitis B surface antigen (HBsAg), or Human Immunodeficiency Virus (HIV) Ab
•7. Abnormal screening laboratory results that are considered clinically significant by the investigator
•8. History of clinical hepatic decompensation, e.g., variceal bleeding, spontaneous bacterial peritonitis, ascites, hepatic encephalopathy or active jaundice (within last year)
•9. Any condition that, in the opinion of the investigator, would compromise the study's objectives or the well-being of the participant or prevent the participant from meeting the study requirements
•10. Participation in an investigational drug trial or having received an investigational vaccine within 30 days or 5 half lives (whichever is longer) prior to study medication
+20 more criteria

Locations (11)

CAP Research Ltd

Phoenix, Mauritius

Republican Clinical Hospital

Chisinau, Moldova

Auckland Clinical Studies

Auckland, New Zealand

Christchurch Clinical Studies Trust

Christchurch, New Zealand

Waikato Hospital

Hamilton, New Zealand

P3 Research Ltd - Hawkes Bay

Havelock North, New Zealand

P3 Research Ltd - Wellington

Wellington, New Zealand

Wellington Hospital

Wellington, New Zealand

King's College Hospital

Brixton, United Kingdom

NHS Greater Glasgow and Clyde Glasgow Royal Infirmary

Glasgow, United Kingdom

Key Dates

Start Date

October 31, 2015

Primary Completion Date

May 11, 2018

Completion Date

May 11, 2018

Last Updated

July 16, 2019

Enrollment

161

ACTUAL participants

Conditions

Chronic Hepatitis C

Interventions

AL-335

DRUG

Odalasvir (ODV)

DRUG

Simeprevir (SMV)

DRUG

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

NCT00199719

Chronic Hepatitis C

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COMPLETEDPHASE4

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

NCT06922643

Chronic Hepatitis C

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COMPLETEDNA

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 16, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir

Inclusion Criteria

Exclusion Criteria

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection