Clinical Trials List
Protocol NumberASC162001
NCT Number(ClinicalTrials.gov Identfier)NCT03020095
2015-09-01 - 2016-08-31
Others
Terminated5
ICD-10B18.2
Chronic viral hepatitis C
ICD-9070.51
Hepatitis C without mention of hepatic coma, acute or unspecified
STUDY TO EVALUATE EFFICACY, SAFETY AND PHARMACOKINETICS OF ASC16 (RAVIDASVIR) IN COMBINATION WITH RITONAVIR-BOOSTED ASC08 (DANOPREVIR) AND RIBAVIRIN IN TREATMENT-NAIVE NON-CIRRHOTIC TAIWANESE PATIENTS WHO HAVE CHRONIC HEPATITIS C GENOTYPE 1.
-
Trial Applicant
ComboTrial Consultancy Ltd .
-
Sponsor
ComboTrial Consultancy Ltd.
-
Trial scale
Taiwan Multiple Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 蘇文邦 Digestive System Department
- Hsueh-Chou Lai Digestive System Department
- 陳昇弘 Digestive System Department
- Hung-Yao Chen Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Chun-Jen Liu Digestive System Department
- 楊宏志 Digestive System Department
- PEI-JER CHEN Digestive System Department
- Chen-Hua Liu Digestive System Department
- 蘇東弘 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Ming-Lun Yeh Digestive System Department
- Chia-Yen Dai Digestive System Department
- Jee-Fu Huang Digestive System Department
- Wan-Long Chuang Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Chronic Hepatitis C Genotype 1
Objectives
The primary objective for this study is as follows:
To evaluate sustained virologic response 12 weeks after end of treatment(SVR12)
The secondary objectives for this study are as follows:
To evaluate the safety, pharmacokinetics, and sustained virologic response 24 weeks after end of treatment(SVR24)
Test Drug
ASC16 & ASC08
Active Ingredient
ASC08(Danoprevir)
ASC16(Ravidasvir)
ASC16(Ravidasvir)
Dosage Form
film-coated tablet
Dosage
100
200
200
Endpoints
1. Primary endpoint(s):
SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration
2. Secondary endpoints:
SVR24, defined as undetectable HCV RNA 24 weeks after the last day of study drug administration
SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration
2. Secondary endpoints:
SVR24, defined as undetectable HCV RNA 24 weeks after the last day of study drug administration
Inclution Criteria
1. Main inclusion criteria: (1) Male and female patients in Taiwan aged 20 years and older (2) Body mass index (BMI, measured as body weight [in kg]/height2 [measured in meters]) between 18.0 and 30.0 (3) A greater than 6 month history of CHC or if in the opinion of the investigator and based on the medical information the patient has chronic hepatitis C virus (HCV). At screening, hepatitis C virus GT1 and serum HCV RNA of 21 x 10 IU/mL are documented (4) Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV (5) Chronic liver disease consistent with CHC infection without cirrhosis as determined by biopsy obtained within the past calendar 36 months using one of the liver biopsy methods in the protocol (non-cirrhosis is defined as: Metavir score < 4), or as determined by Fibroscan defined as: < 14.6 kPa. Patients who have not obtained a liver biopsy or Fibroscan in the last 3 years will have a study related Fibroscan performed in order to confirm the diagnosis. Liver biopsy will be performed based on the investigator s judgement (6) Negative serum or urine pregnancy test result (sensitivity of 25 mIU or better) for women with childbearing potential within the 24-hour period before the first dose of study drugs (7) Female patients with childbearing potential (menopause within 1 year) must agree to use two reliable forms of effective non-hormonal contraception (i.e., condoms, cervical barriers, intrauterine device, spermicides, or sponge), at least 1 of which must be a physical barrier method, during treatment and for at least 6 months following the last dose of ribavirin (8) All male patients with female partners of childbearing potential must use two reliable forms of effective contraception (combined) during treatment and for 6 months following the last dose of ribavirin (9) Ability to participate and willingness to give written informed consent and to comply with the study restrictions
Exclusion Criteria
2. Main exclusion criteria: (1) Pregnant or lactating women. (2) History or presence of decompensated liver disease (history of ascites, hepatic encephalopathy, HCC, or bleeding esophageal varices) (3) Presence or history of non-hepatitis C chronic liver disease, including but not limited to, autoimmune hepatitis, a-1-antitrypsin deficiency, C282Y homozygous hemochromatosis, Wilson' s disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, sclerosing cholangitis, and porphyria cutanea tarda causing liver pathology or requiring phlebotomy (4) Positive hepatitis B surface antigen or HIV antibody at screening (5) History or presence of liver cirrhosis (6) History of severe psychiatric disease, including psychosis and/or depression, who is not able to participate or able to give written informed consent and to comply with the study restrictions (7) History of active malignancy within the last 5 years, with the exception of localized or in situ carcinoma (e.g., basal or squamous cell carcinoma of the skin) (8) History of severe cardiac disease (e.g., New York Heart Association Functional Class II or IV, myocardial infarction within 6 months, ventricular tachyarrhythmia' s requiring ongoing treatment, unstable angina or other unstable, uncontrolled or significant cardiovascular disease within 6 months). Patients with stable coronary artery disease (e.g., 6 months after by-pass surgery, angioplasty with or without stent placement, etc.) as confirmed by a cardiologist will be permitted. In addition, patients with documented or presumed unstable coronary artery disease, cardiovascular disease, or cerebrovascular disease should not be enrolled. (9) Patients with higher potential for corrected QT interval (QTc) prolongation as defined by QT interval corrected using Fridericia' s method (QTCF) 2 450 ms in men or QTCF 2 470 ms in women, or notable resting bradycardia (< 45 beats/min), or notable resting tachycardia (> 100 beats/min) at screening, or personal or family history of congenital long QT syndrome or sudden death (10) Any patient with an increased risk for anemia (e.g., thalassemia, sickle cell anemia, or spherocytosis) or for whom anemia would be medically problematic (11) History of pre-existing renal disease, patients with a history of nephrolithiasis will be allowed (12) Use of blood transfusion growth factors (including, but not limited to, granulocyte colony stimulating factor or erythropoietin) or any other therapeutic agents to elevate hematology parameters to facilitate patient entry into the study within 3 months before screening
(13) Poorly controlled or unstable hypertension; or sustained systolic BP > 150 mm HG or diastolic BP > 95 mm HG at Screen, continued anti-hypertensive use is allowed, for patients with stably-controlled hypertension (14) Poorly controlled diabetes (Hemoglobin Alc value 2 8.5%) and endocrine conditions (15) History of chronic or recurrent infections or acute infection within two weeks prior to Screening (16) Donated or lost > 500 mL of blood within 2 months prior to Screen, or plasma donation within 7 days prior to Screen (17) Although a history of previous statin use is allowed, a requirement for statin use during the study period is prohibited (18) Current enrollment or participation in a clinical trial of an experimental medication including direct acting antivirals (DAA) or medical device within 3 months of screening unless agreed upon by the Sponsor (19) Any of the following laboratory parameters at screening: @ Total bilirubin 2 2 x the upper limit of normal (ULN) or 47 umol/L (2.75 mg/dL) for Gilbert' s syndrome 2 Hemoglobin < 110 g/L (< g/dL) for women or < 120 g/L (< 12 g/dL) for men O Absolute neutrophil count (ANC) s 1.5 x 109/L (1500/µL) 4 Platelet count < 100,000/µl
5 Any other abnormal screening laboratory result that is considered to be clinically significant by the investigator (20) Use of the following concomitant medications or herbal supplements: O Inducers of metabolic enzymes (e.g., rifampin, rifabutin, phenobarbital, phenytoin, carbamazepine, and St John' swort) within 14 days or 5 half-lives (whichever is longer) before the first dose of ASC16/ASC08/r and while on treatment with ASC16/ASC08/r 2 "Potent" inhibitors of CYP3A (e.g., ketoconazole) within 7 days or 5 half-lives (whichever is longer) before the first dose of ASC16/ASC08/r and while receiving ASC16/ ASC08/r treatment ® Inhibitors of organic anion transporting polypeptide (OATP transporters) (e.g., cyclosporine, rifampicin) within 7 days before the first dose of ASC16/ASC08/r and while receiving treatment with ASC16/ASC08/r 4 Medications that are contraindicated with ritonavir (RTV), including but not limited to alfuzosin, amiodarone, bepridil, flecainide, propafenone, quinidine, voriconazole, astemizole, terfenadine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, sildenafil (for treatment of pulmonary arterial hypertension), midazolam, triazolam, atorvastatin, lovastatin, and simvastatin 6 Medications with a narrow therapeutic window that are extensively metabolized by CYP3A and/or substrates of the P-glycoprotein transporter 6 Evidence of excessive alcohol, drug or substance abuse (excluding marijuana use) within 1 year of first dose. O History of allergy to RBV, ASC16, ASC08 or RTV or any of their ingredients.
(13) Poorly controlled or unstable hypertension; or sustained systolic BP > 150 mm HG or diastolic BP > 95 mm HG at Screen, continued anti-hypertensive use is allowed, for patients with stably-controlled hypertension (14) Poorly controlled diabetes (Hemoglobin Alc value 2 8.5%) and endocrine conditions (15) History of chronic or recurrent infections or acute infection within two weeks prior to Screening (16) Donated or lost > 500 mL of blood within 2 months prior to Screen, or plasma donation within 7 days prior to Screen (17) Although a history of previous statin use is allowed, a requirement for statin use during the study period is prohibited (18) Current enrollment or participation in a clinical trial of an experimental medication including direct acting antivirals (DAA) or medical device within 3 months of screening unless agreed upon by the Sponsor (19) Any of the following laboratory parameters at screening: @ Total bilirubin 2 2 x the upper limit of normal (ULN) or 47 umol/L (2.75 mg/dL) for Gilbert' s syndrome 2 Hemoglobin < 110 g/L (< g/dL) for women or < 120 g/L (< 12 g/dL) for men O Absolute neutrophil count (ANC) s 1.5 x 109/L (1500/µL) 4 Platelet count < 100,000/µl
5 Any other abnormal screening laboratory result that is considered to be clinically significant by the investigator (20) Use of the following concomitant medications or herbal supplements: O Inducers of metabolic enzymes (e.g., rifampin, rifabutin, phenobarbital, phenytoin, carbamazepine, and St John' swort) within 14 days or 5 half-lives (whichever is longer) before the first dose of ASC16/ASC08/r and while on treatment with ASC16/ASC08/r 2 "Potent" inhibitors of CYP3A (e.g., ketoconazole) within 7 days or 5 half-lives (whichever is longer) before the first dose of ASC16/ASC08/r and while receiving ASC16/ ASC08/r treatment ® Inhibitors of organic anion transporting polypeptide (OATP transporters) (e.g., cyclosporine, rifampicin) within 7 days before the first dose of ASC16/ASC08/r and while receiving treatment with ASC16/ASC08/r 4 Medications that are contraindicated with ritonavir (RTV), including but not limited to alfuzosin, amiodarone, bepridil, flecainide, propafenone, quinidine, voriconazole, astemizole, terfenadine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, sildenafil (for treatment of pulmonary arterial hypertension), midazolam, triazolam, atorvastatin, lovastatin, and simvastatin 6 Medications with a narrow therapeutic window that are extensively metabolized by CYP3A and/or substrates of the P-glycoprotein transporter 6 Evidence of excessive alcohol, drug or substance abuse (excluding marijuana use) within 1 year of first dose. O History of allergy to RBV, ASC16, ASC08 or RTV or any of their ingredients.
The Estimated Number of Participants
-
Taiwan
40 participants
-
Global
40 participants
