Clinical trial NCT01180790: Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants
Official title: A Phase IIa, Randomized, Double-blind (Participant and Investigator Blind, Sponsor Open), Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Antiviral Activity of Oral ACH-0141625 in Combination With Pegylated Interferon Alpha-2a and Ribavirin in Two Segments, After 28 Days of Dosing and, Subsequently, After 12 Weeks of Dosing in Participants With Chronic Hepatitis C Virus Genotype 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Keywords: HCV
Hepatitis C Genotype 1
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Achillion, a wholly owned subsidiary of Alexion
First posted: 2010-08-12
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate safety, tolerability, and antiviral response of ACH-0141625 compared to standard of care in hepatitis C virus (HCV)-positive participants.


Eligibility criteria: Inclusion Criteria:

* Males and females, aged 18 years and older
* Chronic hepatitis C genotype 1 (as specified in the protocol)
* Treatment naive
* Females who are post-menopausal and amenorrheic must have a follicle-stimulating hormone (FSH) at screening. Females of childbearing potential must have a negative pregnancy test at screening and baseline. Females must use a non-hormonal method of contraception and must agree not to get pregnant during the study and for 6 months following the discontinuation of standard of care (SOC).
* Fertile males must agree to use a condom and his female partner must agree to use 1 or more methods of contraception. Males must not donate sperm during the study and 3 months following the last exposure to RBV.

Exclusion Criteria:

* Body mass index (BMI) \>36 kilograms (kg)/square meter (m\^2)
* Pregnant or nursing females or females of childbearing potential not willing to comply with contraceptive measures per protocol. Men whose female partners are pregnant or contemplating pregnancy. - Coinfection with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV)
* Other significant diseases including liver disease
* History of drug or alcohol dependence or addiction within the past 6 months
* History of participation in a clinical trial with a protease inhibitor or previous treatment with a protease inhibitor, where at least 1 dose of the protease inhibitor was consumed.
* Use of herbal or homeopathic products, illicit drugs, cytochrome P450 (CYP) 3A4/5 substrates, inducers or inhibitors, hormonal methods of contraception, corticosteroids, immunosuppressive, or cytotoxic agents within 28 days of the first dose of study drug.
* Have a clinically significant laboratory abnormality at screening (as specified in the protocol).
* Segment 1: Participants with any history of decompensated liver disease defined as cirrhotic participants with a Child-Pugh score of \> or = to 7. Segment 2: Participants who have had a liver biopsy that shows bridging fibrosis or cirrhosis.
* Nonalcoholic steatohepatitis if ballooning degeneration or Mallory bodies are present on liver biopsy.
* Participants who prematurely discontinued, interrupted, or dose reduced prior Peg-IFN and RBV therapy due to noncompliance or safety issues.
* Encephalopathy or altered mental status of any etiology.
* History of moderate, severe, or uncontrolled psychiatric disease (as specified in the protocol).
* History of malignancy of any organ system treated or untreated within the past 5 years.
* Use of colony stimulating factor agents within 90 days prior to baseline.
* History of seizure disorder.
* History of known coagulopathy including hemophilia.
* Clinically of significant findings on fundoscopic or retinal examination at screening
* History of immunologically mediate disease.
* History of clinical evidence of chronic cardiac disease (as specified in the protocol)
* Received concomitant systemic antibiotic, antifungals, or antivirals for the treatment of active infection within 14 days prior to the first dose of the study drug (as specified in the protocol)

Primary outcomes:
measure: Segment 1: Safety
timeFrame: 4 weeks
measure: Segment 1: Rapid Viral Response At Week 4 (RVR4)
timeFrame: 4 weeks
measure: Segment 2: Safety
timeFrame: 12 weeks
measure: Segment 2: Complete Early Virologic Response (cEVR)
timeFrame: Week 12
Secondary outcomes:
measure: Segment 1: cEVR
timeFrame: 12 weeks
measure: Segment 2: RVR4
timeFrame: 4 weeks
measure: Segment 1 And Segment 2: End Of Treatment Response
timeFrame: Week 48 (Segment 1); Week 24 (Segment 2)
measure: Segment 1 And Segment 2: Sustained Virologic Response 12 Weeks (3 Months Post-dosing) (SVR12)
timeFrame: 3 months post-dosing
measure: Segment 1 And Segment 2: Sustained Virologic Response 24 Weeks (6 Months Post-dosing) (SVR24)
timeFrame: 6 months post-dosing
measure: Segment 1 And Segment 2: HCV RNA Change From Baseline
timeFrame: Week 4
measure: Segment 1 And Segment 2: HCV RNA Change From Baseline
timeFrame: Week 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Clinical Trial Site
state: California
city: Los Angeles
country: United States
facility: Clinical Trial Site
state: California
city: San Francisco
country: United States
facility: Clinical Trial Site
state: California
city: Bradenton
country: United States
facility: Clinical Trial Site
state: Florida
city: Orlando
country: United States
facility: Clinical Trial Site
state: Florida
city: Chicago
country: United States
facility: Clinical Trial Site
state: Illinois
city: Overland Park
country: United States
facility: Clinical Trial Site
state: Kansas
city: Saint Louis
country: United States
facility: Clinical Trial Site
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Trial Site
state: Nevada
city: New York
country: United States
facility: Clinical Trial Site
state: New York
city: Philadelphia
country: United States
facility: Clinical Trial Site
state: Pennsylvania
city: Arlington
country: United States
facility: Clinical Trial Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Trial Site
state: Texas
city: Newport News
country: United States
facility: Clinical Trial Site
state: Virginia
city: Norfolk
country: United States
facility: Clinical Trial Site
state: Virginia
city: Edegem
country: Belgium
facility: Clinical Trial Site
state: Antwerp
city: Haine-Saint-Paul
country: Belgium
facility: Clinical Trial Site
state: Hainaut
city: Gent
country: Belgium
facility: Clinical Trial Site
state: Oost-Vlaanderen
Study officials:
References: