Clinical Trials List
2015-11-01 - 2018-03-31
Phase III
Terminated14
ICD-10B18.2
Chronic viral hepatitis C
ICD-10B18
Chronic viral hepatitis
A Phase 3b Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 weeks in Subjects with Chronic Genotype 1 or 2 Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Coinfection
-
Trial Applicant
GILEAD SCIENCES HONG KONG LIMITED
-
Sponsor
Gilead Sciences
-
Trial scale
Taiwan Multiple Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 陳昇弘 無
- Hung-Yao Chen 無
- 蘇文邦 無
- Hsueh-Chou Lai 無
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 曾志偉 無
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 林崇棋 無
The Actual Total Number of Participants Enrolled
6 Terminated
Audit
None
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 邱彥程 無
- 吳毅晉 無
- Chiu Hung Chiu 無
- Pin-Nan Cheng 無
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳威廷 無
- Yi-Chung Hsieh 無
- Yi-Cheng Chen 無
- 滕威 無
- Wen-Juei Jeng 無
- Chun-Yen Lin 無
- Chien-Hao Huang 無
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 張家昌 無
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Chen-Hua Liu 無
- 楊宏志 無
- Jia-Horng Kao 無
- 蘇東弘 無
- PEI-JER CHEN 無
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Sofosbuvir
Dosage Form
Dosage
400
Endpoints
Efficacy: Efficacy will be evaluated using scheduled assessments of HCV RNA performed using COBAS TaqMan HCV Test, v2.0 for use with the Ampliprep.
Pharmacokinetics: A single PK blood sample will be collected at each on-treatment visit and ET visit (as applicable) for all subjects, except for Day 1. The PK of SOF (and its metabolites GS-566500 and GS-331007) and LDV may be assessed.
Inclution Criteria
Subjects must meet all of the following inclusion criteria to be eligible for participation in this
study.
1) Willing and able to provide written informed consent.
2) Male or female, age 20 years.
3) Weight ≥ 40 kg.
4) HCV genotype 1 or 2 at Screening as determined by the central laboratory.
5) Chronic HCV infection (≥ 6 months prior to Day 1) documented by prior medical history or liver biopsy.
6) Chronic HBV infection defined as one of the following:
a) HBsAg or HBV DNA positivity for at least 6 months prior to Day 1 visit, or
b) Medical records indicating a chronic HBV infection
7) HCV treatment status defined as one of the following:
a) HCV treatment-naïve: Subject has had no prior exposure to any approved or experimental
IFN or HCV-specific direct-acting antiviral agents (DAAs).
b) HCV treatment-intolerant: Subjects that discontinued HCV treatment due to development
or significant worsening of a treatment related adverse event.
c) HCV treatment-experienced: Prior virologic failure after treatment with
Pegylated-Interferon plus ribavirin (PEG/RBV) regimen, including those who have failed
treatment with an NS3/4A protease inhibitor plus PEG/RBV. Subjects must not have
discontinued prior therapy due to non-compliance.
8) Subject must not be taking or require treatment with HBV antiviral therapy during Screening.
However, subjects must be able to take and have access to HBV standard of care therapy if
required during the study.
9) Cirrhosis Determination at Screening
i) Presence of cirrhosis is defined as transient elastography (FibroScan®) with a result of >12.5 kPa
ii) Absence of cirrhosis is defined as transient elastography (FibroScan® ) with a result of ≤ 12.5 kPa
10) Liver imaging by ultrasound is required to exclude hepatocellular carcinoma (HCC) at Screening
11) Screening ECG without clinically significant abnormalities.
12) Subject has not been treated with any investigational drug or device within 28 days of the Screening visit.
13) Subjects must have the following laboratory parameters at Screening:
a) ALT ≤ 10 x the upper limit of normal (ULN)
b) AST ≤ 10 x ULN
c) Direct bilirubin ≤ 2 x ULN
d) HbA1c ≤ 8.5%
e) Platelets ≥ 50,000/L
f) Creatinine clearance (CLcr) ≥ 50 mL/min, as calculated by the Cockcroft-Gault equation
{2202}
g) Hemoglobin ≥ 10 g/dL
h) Albumin ≥ 3g/dL
i) INR ≤ 1.5 x ULN; INR criteria does not pertain to subjects with known hemophilia or is
stable on an anticoagulant regimen affecting INR.
14) Females of childbearing potential (as defined in Appendix 4) must have a negative serum
pregnancy test at Screening and a negative urine pregnancy test on Day 1 prior to enrollment.
15) Male subjects and female subjects of childbearing potential who engage in heterosexual
intercourse must agree to use protocol specified method(s) of contraception as described in
Appendix 4.
16) Lactating females must agree to discontinue nursing before the study drug is administered.
17) Subject must be of generally good health, with the exception of chronic HCV/HBV infection,
as determined by the Investigator
18) Subject must be able to comply with the dosing instructions for study drug administration
and able to complete the study schedule of assessments
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
1) Current or prior history of any of the following:
a) Clinically-significant illness (other than HCV or HBV) or any other major medical
disorder that may interfere with subject treatment, assessment or compliance with the
protocol; subjects currently under evaluation for a potentially clinically-significant illness
are also excluded.
b) Gastrointestinal disorder or post-operative condition that could interfere with the
absorption of the study drug.
c) Difficulty with blood collection and/or poor venous access for the purposes of
phlebotomy.
d) Clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage).
e) Solid organ transplantation
f) Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of
their psychiatric illness within the last 2 years.
g) Malignancy within 5 years prior to screening, with the exception of specific cancers that
are entirely cured by surgical resection (basal cell skin cancer, etc.). Subjects under
evaluation for possible malignancy are not eligible.
h) Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatotoxicity).
2) Pregnant or nursing female
3) Chronic liver disease of a non-HCV/HBV etiology (e.g., hemochromatosis, Wilson’s disease,
alpha-1 antitrypsin deficiency, cholangitis).
4) Infection with human immunodeficiency virus (HIV) or Hepatitis Delta virus (HDV).
5) Clinically-relevant drug or alcohol abuse within 12 months of screening. A positive drug
screen will exclude subjects unless it can be explained by a prescribed medication; the
diagnosis and prescription must be approved by the investigator.
6) Use of any prohibited concomitant medications as described in Section 5.4.
7) Known hypersensitivity to LDV, SOF, metabolites or formulation excipients.
The Estimated Number of Participants
-
Taiwan
100 participants
-
Global
100 participants
