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Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6

Primary Purpose

PT-NANBH

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

8 weeks SOF/LED

12 weeks SOF/LED

About this trial

This is an interventional treatment trial for PT-NANBH focused on measuring hepatitis C, genotype 6

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Stanford University Medical Center
San Jose Gastroenterology
Liver and Digestive Consultants
Digestive Health Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

8 weeks SOF/LED

12 weeks SOF/LED

Arm Description

Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.

Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.

Outcomes

Primary Outcome Measures

Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment

Secondary Outcome Measures

Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment.

Adverse events were defined using Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

Full Information

NCT ID

NCT02480166

First Posted

June 17, 2015

Last Updated

August 21, 2017

Sponsor

Stanford University

Collaborators

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02480166

Brief Title

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

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

Gilead Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objectives of this study are to describe the efficacy of: 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PT-NANBH

Keywords

hepatitis C, genotype 6

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

8 weeks SOF/LED

Arm Type

Experimental

Arm Description

Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.

Arm Title

12 weeks SOF/LED

Arm Type

Experimental

Arm Description

Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.

Intervention Type

Drug

Intervention Name(s)

8 weeks SOF/LED

Other Intervention Name(s)

Harvoni, Solvaldi

Intervention Description

Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.

Intervention Type

Drug

Intervention Name(s)

12 weeks SOF/LED

Other Intervention Name(s)

Harvoni, Solvaldi

Intervention Description

Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.

Primary Outcome Measure Information:

Title

Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment

Time Frame

12 weeks after end of therapy

Secondary Outcome Measure Information:

Title

Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment.

Description

Adverse events were defined using Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

Time Frame

Day 1 of treatment to 12 weeks post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, age ≥18 years HCV genotype 6 or indeterminate and later assessed at Screening and confirmed as genotype 6 Selected to start on treatment by their treating providers Willing and able to provide informed consent Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative pregnancy test on Baseline Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception Lactating females must agree to discontinue nursing before the study drug is administered Exclusion Criteria: Previous recipient of a liver transplant Co-infection with human immunodeficiency virus (HIV) or hepatitis B (HBV)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mindie H Nguyen, MD, MAS

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University Medical Center

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

San Jose Gastroenterology

City

San Jose

State/Province

California

ZIP/Postal Code

95128

Country

United States

Facility Name

Liver and Digestive Consultants

City

Houston

State/Province

Texas

ZIP/Postal Code

77072

Country

United States

Facility Name

Digestive Health Associates

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23944316

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.

Results Reference

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PubMed Identifier

21038410

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.

Results Reference

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PubMed Identifier

24725238

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.

Results Reference

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PubMed Identifier

24725239

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.

Results Reference

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PubMed Identifier

21623850

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.

Results Reference

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Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6

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