Clinical trial NCT02480166: Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6
Official title: Comparative Efficacy of Fixed-dose Combination of Sofosbuvir and Ledipasvir for 8 or 12 Weeks for Chronic Hepatitis C Genotype 6
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PT-NANBH
Keywords: hepatitis C, genotype 6
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2015-06-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objectives of this study are to describe the efficacy of:

1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6
2. 12-week treatment of SOF/LED for all other HCV-6 populations

Detailed description: The secondary objective of this study is to describe safety, persistency, and tolerability of SOF/LED in patients with HCV-6.

Eligibility criteria: Inclusion Criteria:

1. Male or female, age ≥18 years
2. HCV genotype 6 or indeterminate and later assessed at Screening and confirmed as genotype 6
3. Selected to start on treatment by their treating providers
4. Willing and able to provide informed consent
5. Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments
6. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative pregnancy test on Baseline
7. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
8. Lactating females must agree to discontinue nursing before the study drug is administered

Exclusion Criteria:

1. Previous recipient of a liver transplant
2. Co-infection with human immunodeficiency virus (HIV) or hepatitis B (HBV)

Primary outcomes:
measure: Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment
timeFrame: 12 weeks after end of therapy
Secondary outcomes:
measure: Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment.
timeFrame: Day 1 of treatment to 12 weeks post treatment
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: San Jose
country: United States
facility: San Jose Gastroenterology
state: California
city: Houston
country: United States
facility: Liver and Digestive Consultants
state: Texas
city: Plano
country: United States
facility: Digestive Health Associates
state: Texas
Study officials:
affiliation: Stanford University
name: Mindie H Nguyen, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lawitz E, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 Aug 15;369(7):678-9. doi: 10.1056/NEJMc1307641. No abstract available.
citation: Lam KD, Trinh HN, Do ST, Nguyen TT, Garcia RT, Nguyen T, Phan QQ, Nguyen HA, Nguyen KK, Nguyen LH, Nguyen MH. Randomized controlled trial of pegylated interferon-alfa 2a and ribavirin in treatment-naive chronic hepatitis C genotype 6. Hepatology. 2010 Nov;52(5):1573-80. doi: 10.1002/hep.23889.
citation: Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, Nahass R, Ghalib R, Gitlin N, Herring R, Lalezari J, Younes ZH, Pockros PJ, Di Bisceglie AM, Arora S, Subramanian GM, Zhu Y, Dvory-Sobol H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Sulkowski M, Kwo P; ION-2 Investigators. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014 Apr 17;370(16):1483-93. doi: 10.1056/NEJMoa1316366. Epub 2014 Apr 11.
citation: Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, Romero-Gomez M, Zarski JP, Agarwal K, Buggisch P, Foster GR, Brau N, Buti M, Jacobson IM, Subramanian GM, Ding X, Mo H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Mangia A, Marcellin P; ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15;370(20):1889-98. doi: 10.1056/NEJMoa1402454. Epub 2014 Apr 11.
citation: Chao DT, Abe K, Nguyen MH. Systematic review: epidemiology of hepatitis C genotype 6 and its management. Aliment Pharmacol Ther. 2011 Aug;34(3):286-96. doi: 10.1111/j.1365-2036.2011.04714.x. Epub 2011 May 29.