Clinical trial NCT01716156: A Study of Different Durations of Treatment With Grazoprevir (MK-5172) in Combination With Ribavirin in Participants With Chronic Hepatitis C (MK-5172-039)
Official title: A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of MK-5172 in Combination With Ribavirin (RBV) in Subjects With Chronic Hepatitis C Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-10-29
Enrollment: 26
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: This study will compare two different durations of treatment with grazoprevir (MK-5172) in combination with ribavirin (RBV) in treatment-naïve non-cirrhotic interferon-eligible interleukin 28b CC (IL28B CC) genotype participants with genotype 1 (GT1)-positive chronic hepatitis C (CHC). Participants will be randomized to receive 12 or 24 weeks of combination therapy.


Eligibility criteria: Inclusion Criteria:

* Chronic, compensated HCV GT 1 hepatitis C
* IL28B CC genotype
* Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease, or cirrhosis
* No evidence of cirrhosis and hepatocellular carcinoma by biopsy or noninvasive tests (FibroScan and/or FibroTest)
* Agree to use two acceptable methods of birth control from at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations (for female subject who is of childbearing potential or male subject with female sexual partner who is of childbearing potential)

Exclusion Criteria:

* Non-GT 1 HCV infection, including a mixed GT infection (with a non-GT 1) or a non-typeable genotype
* Previous treatment with any interferon, RBV, approved or experimental direct acting antiviral(s), or other investigational therapies for HCV
* Human immunodeficiency virus (HIV) positive or known to be co-infected with hepatitis B virus
* Evidence of hepatocellular carcinoma (HCC) or under evaluation for HCC
* Currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another study
* Diabetes and/or hypertension with clinically significant ocular examination findings
* Current moderate or severe depression or history of depression associated with hospitalization, electroconvulsive therapy, or severe disruption of daily functions, or suicidal or homicidal ideation and/or attempt, or history of severe psychiatric disorders
* Clinical diagnosis of substance abuse
* Current or history of seizure disorder, stroke, or transient ischemic attack
* Immunologically-mediated disease
* Chronic pulmonary disease
* Clinically significant cardiac abnormalities/dysfunction
* Active clinical gout within the last year
* Hemoglobinopathy or myelodysplastic syndromes
* History of organ transplants
* Poor venous access
* Indwelling venous catheter
* History of gastric surgery or malabsorption disorder
* Severe concurrent disease
* Evidence of active or suspected malignancy, or under evaluation for malignancy, or history of malignancy, within the last 5 years
* Pregnant, lactating, or expecting to conceive or donate eggs
* Male participant whose female partner is pregnant
* Member or a family member of the investigational study staff or sponsor staff directly involved with this study
* History of chronic hepatitis not caused by HCV

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)
timeFrame: Up to Week 36
measure: Percentage of Participants Experiencing at Least One Adverse Event (AE) on Study
timeFrame: Fourteen days following last dose of study drug (up to 26 weeks)
measure: Percentage of Participants Discontinuing Study Therapy Due to an AE
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Time to Achievement of First Undetectable HCV RNA
timeFrame: Up to Week 24
measure: Percentage of Participants With Undetectable HCV RNA by Time Point
timeFrame: From Week 2 through end of treatment (up to 24 weeks)
measure: Percentage of Participants With HCV RNA <25 IU/mL by Time Point
timeFrame: From Week 2 through end of treatment (up to 24 weeks)
measure: Percentage of Participants With Sustained Virologic Response 4 Weeks After Ending Study Therapy (SVR4)
timeFrame: Up to Week 28
measure: Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR 24)
timeFrame: Up to Week 48
Other outcomes:
Locations:
Study officials:
References:
citation: Gane E, Ben Ari Z, Mollison L, Zuckerman E, Bruck R, Baruch Y, Howe AY, Wahl J, Bhanja S, Hwang P, Zhao Y, Robertson MN. Efficacy and safety of grazoprevir + ribavirin for 12 or 24 weeks in treatment-naive patients with hepatitis C virus genotype 1 infection. J Viral Hepat. 2016 Oct;23(10):789-97. doi: 10.1111/jvh.12552. Epub 2016 Jun 12.