yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm - LARVOL DELTA

To Evaluate the Pharmacokinetics and Safety of Yimitasvir Phosphate Capsules in Subjects With Moderate and Severe Liver Function Impairment and in Healthy Subjects (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Sunshine Lake Pharma Co., Ltd. | Recruiting ➔ Completed | N=32 ➔ 16 | Trial completion date: Oct 2022 ➔ Jun 2022 | Trial primary completion date: Sep 2022 ➔ Jun 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Hepatology

Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and ESRD (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Sunshine Lake Pharma Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Oct 2022 ➔ May 2022 | Trial primary completion date: Oct 2022 ➔ May 2022

Trial completion • Trial completion date • Trial primary completion date • Chronic Kidney Disease • Nephrology • Renal Disease

Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and ESRD (clinicaltrials.gov) - P1; N=16; Recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.; Not yet recruiting ➔ Recruiting; Initiation date: Oct 2020 ➔ Apr 2021

Clinical • Enrollment open • Trial initiation date • Chronic Kidney Disease • Nephrology • Renal Disease

To Evaluate Efficacy and Safety in TG-2349 Combination With DAG181 (± Ribavirin) in HCV Genotype I Infected Patients (clinicaltrials.gov) - P2; N=133; Completed; Sponsor: Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.; Recruiting ➔ Completed

Clinical • Trial completion • Fibrosis • Hepatitis C Virus • Hepatology • Immunology

Population Pharmacokinetic Analysis of Yimitasvir in Chinese Healthy Volunteers and Patients With Chronic Hepatitis C Virus Infection. (PubMed, Front Pharmacol) - "Food decreased Ka and F significantly, so it was recommended to take yimitasvir at least 2 h before or after a meal. Other significant covariates were not clinically important."

Clinical • Journal • PK/PD data • Hepatitis C Virus • Hepatology • Infectious Disease

A Phase III Study to Evaluate Efficacy and Safety of TG-2349 in Combination With DAG181 and RBV for HCV Type I Patients (clinicaltrials.gov) - P3; N=370; Completed; Sponsor: Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.; Recruiting ➔ Completed

Clinical • Combination therapy • Trial completion • Fibrosis • Hepatitis C Virus • Hepatology • Immunology • AFP • ALB

Evaluation of drug-drug interactions between yimitasvir phosphate capsules with sofosbuvir tablets, omeprazole magnesium enteric-coated tablets, and rosuvastatin calcium tablets (PubMed, Zhonghua Gan Zang Bing Za Zhi) - "There were no serious adverse events and adverse events leading to withdrawal from the trial. Yimitasvir phosphate capsules have drug-drug interactions with sofosbuvir tablets, omeprazole magnesium enteric-coated tablets, and rosuvastatin calcium tablets."

Clinical • Journal • Hepatology • Infectious Disease

Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and ESRD (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.

Clinical • New P1 trial • Chronic Kidney Disease • Nephrology • Renal Disease

To Evaluate the Pharmacokinetics and Safety of Yimitasvir Phosphate Capsules in Subjects With Moderate and Severe Liver Function Impairment and in Healthy Subjects (clinicaltrials.gov) - P1; N=32; Recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.

New P1 trial • Hepatology • Liver Failure