Hepatitis C Study with GT 1 2 and 3.

Phase 1

Active, not recruiting

• Conditions: Chronic Hepatitis C infection; MedDRA version: 20.0 Level: LLT Classification code 10076789 Term: Chronic hepatitis C genotype 2 System Organ Class: 100000004862; MedDRA version: 20.0 Level: LLT Classification code 10076831 Term: Chronic hepatitis C genotype 3 System Organ Class: 100000004862; MedDRA version: 20.0 Level: LLT Classification code 10076786 Term: Chronic hepatitis C genotype 1 System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-002845-46-GB
• Lead Sponsor: Alios BioPharma, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-11
• Study Completion: 2018-05-11
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 161

Inclusion Criteria

1. Subject has provided written consent.
2. In the Investigator’s opinion, the subject 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 kg/m2, inclusive.
5. A woman of childbearing potential must have a negative serum (ß-human chorionic gonadotropin) pregnancy test at screening.
6. Female subjects must either:
- not be of childbearing potential
or
- be of childbearing potential and not heterosexually active or if heterosexually active, have a vasectomized partner or be using an acceptable method of birth control
7. Male subjects must either:
- be surgically sterile
- not be heterosexually active
- if heterosexually active, have a partner who is postmenopausal or be practicing an acceptable method of birth control
8. Subjects must agree to refrain from sperm/egg donation from start of dosing through 6 months after the completion of study drug administration.
9. GT1a or 1b or GT2 or 3 CHC, depending on cohort, with positive HCV antibody and a positive HCV RNA at screening including documentation of CHC infection for at least 6 months. Genotype testing must occur at a screening visit.
10. Screening HCV RNA viral load =50,000 IU/mL, except for subjects with compensated cirrhosis (Child-Pugh Class A) who may have HCV RNA viral load =104 IU/mL.
11. Treatment naïve (i.e. no prior exposure to any approved or investigational drug(s) including direct-acting antivirals, and interferon-based treatment regimens) or, in subjects with cirrhosis, treatment experienced (defined as subjects who experienced virologic relapse after receiving a full course of pegylated interferon+ribavirin (peg/riba) treatment). Prior use of any direct acting antiviral in combination with peg/riba is not permitted.
12. Fibroscan, collected within 6 months of baseline visit, with liver stiffness score =12.5 kPa to be eligible
13. Subject is otherwise in good health as deemed by the investigator, based on the findings of a medical evaluation including medical history, physical examination, laboratory tests and ECG.
14. Willing to avoid prolonged sun exposure and use of tanning devices while taking SMV and through 4 weeks of follow up. Subjects should also be advised to use a broad-spectrum sunscreen and lip balm of at least sun protection factor >30 to help protect against potential sunburn.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

1. Pregnant, planning on becoming pregnant (during treatment and up to 6 months after the EOT), or breast-feeding female subject, or male subject 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% or any other echocardiographic finding suggestive of clinically relevant cardiomyopathy.
5. Creatinine clearance of <60 mL/min (Cockcroft-Gault).
6. Positive test for HAV IgM, HBsAg, or 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 subject or prevent the subject 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.
11. Clinically significant abnormal screening ECG findings (e.g., PR >200 msec, QRS interval >120 msec or corrected QT interval (QTc) >450 msec for male subjects and >470 msec for female subjects), based on an average of triplicate ECGs. Any evidence of heart block or bundle branch block is also exclusionary.
12. History or family history of abnormal ECG intervals, for example prolonged QT syndrome (torsade de pointes) or sudden cardiac death.
13. The subject has a positive prestudy drug screen, including methadone unless the drug is prescribed by the subject’s physician. The list of drugs that should be screened for includes amphetamines, barbiturates, cocaine, opiates, phencyclidine (PCP), and benzodiazepines. Drug use without a physician prescription may be permitted on a case by case basis after review by the Sponsor in consultation with the investigator.
14. Laboratory abnormalities including: Hematocrit, White blood cell counts, Absolute neutrophil count, Platelets, Glycosylated hemoglobin, Prothrombin time, Albumin, Serum ALT concentration, CK
15. Any condition possibly affecting drug absorption (e.g., gastrectomy or other significant gastrointestinal tract surgery, such as gastroenterostomy, small bowel resection, or active enterostomy).
16. Clinically significant blood loss or elective blood donation of significant volume (i.e., >500 mL) within 60 days of first dose of study drug; >1 unit of plasma within 7 days of

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified