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Hepatitis C, Chronic clinical trials

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NCT ID: NCT04387526 Completed - Clinical trials for Chronic Hepatitis C Virus Infection

Sofosbuvir Plus Daclatasvir With or Without Ribavirin and Chronic HCV Genotype (GT) 4

Start date: April 1, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.

NCT ID: NCT04385407 Completed - Clinical trials for Chronic Hepatitis C Virus Infection

Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients

Start date: April 2015
Phase: Phase 2
Study type: Interventional

A total of 201 participants with chronic HCV GT4 infection were allocated into two groups. One group participants were treated with SOF plus RBV (24 weeks). The second group was treated with SOF plus SMV (12 weeks).

NCT ID: NCT04382937 Completed - Clinical trials for Chronic Hepatitis C Virus Infection

Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection

Start date: January 12, 2016
Phase: Phase 3
Study type: Interventional

Primary objective: To demonstrate non-inferiority in sustained virologic response (SVR, undetectable HCV RNA at Follow up week 12) between PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily and P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily for the treatment of chronic HCV genotype 2 infection

NCT ID: NCT04382404 Completed - Clinical trials for Hepatitis C, Chronic

Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir

Start date: October 22, 2020
Phase: Phase 1
Study type: Interventional

A single-arm, single-center, open label Phase 1 study of a 12-week course of Sofosbuvir (SOF)/Velpatasvir (VEL) in 10 HCV-infected pregnant women 1 that will evaluate the plasma pharmacokinetic parameters of SOF/VEL administered during pregnancy and compare them to those of a historical cohort of nonpregnant women.

NCT ID: NCT04352309 Completed - Clinical trials for Hepatitis C Virus (HCV)

Efficacy Study Of Oral Glecaprevir/Pibrentasvir Tablet In Pediatric (12 Years and Older) And Adult Treatment-Naive Participants With Chronic Hepatitis C Genotypes 1 To 6 And Liver Cirrhosis

EASY
Start date: May 29, 2020
Phase:
Study type: Observational

Hepatitis C Virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver) and liver cancer leaving trial participants with need for liver transplant. The purpose of this study is to see how effective Glecaprevir/Pibrentasvir (GLE/PIB) is in a real world setting of participants with chronic HCV genotypes 1 to 6 and liver cirrhosis who have never received any treatment for HCV. GLE/PIB is a drug developed for the treatment of HCV infection. This is a prospective (future), observational study in treatment-naive (those who have not received treatment) participants with HCV genotypes 1 to 6 and compensated cirrhosis. All study participants will receive GLE/PIB as prescribed by their study doctor in accordance with approved local label. Pediatric (12 years and older) and adult participants with a diagnosis of HCV genotypes 1 to 6 and compensated cirrhosis will be enrolled in the study in Russian Federation. Participants will receive GLE/PIB tablets to be taken by mouth daily according to their physicians' prescription. The total duration of the study is 20 weeks, with a treatment period of 8 weeks and a follow up period of 12 weeks. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 12 weeks.

NCT ID: NCT04330508 Completed - Clinical trials for Depression in Chronic Hepatitis C

Effects of Direct-acting Antiviral Agents on HCV Cognitive Function, and Depression in HCV Related Cirrhosis: A Prospective Clinical Trial

Start date: March 1, 2018
Phase:
Study type: Observational

Minimal hepatic encephalopathy (MHE) is an important clinical variant of hepatic encephalopathy (HE), which occurs in up to 60-70% of patients with cirrhosis. The condition comprises a cognitive impairment, observed in patients with cirrhosis who have no clinical evidence of overt hepatic encephalopathy (OHE). It is associated with an increased incidence of road traffic accidents, reduced quality of life and it affects the ability to perform tasks of daily living. Successful treatment of hepatitis C has been reported to be associated with 62-84% reduction in all-cause mortality (deaths), 68-79% reduction in risk of HCC and 90% reduction in risk of liver transplantation. In addition, studies have shown that viral eradication may improve cognition when given interferon based regimens for HCV. With the available of safe, efficacious, all oral regimens for HCV, we plan to prospectively analyse the change in mood, depression and cognitive function in response to DAA therapy, in relation to outcomes of treatment.

NCT ID: NCT04246723 Completed - Clinical trials for Chronic Hepatitis c Genotype 1

Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Sofosbuvir in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1

Start date: May 6, 2019
Phase: Phase 2
Study type: Interventional

Multicenter, open-label, phase II safety and efficacy study of all-oral combination of narlaprevir/ritonavir and sofosbuvir in Treatment-naïve Patients with Chronic Hepatitis C Genotype 1.

NCT ID: NCT04232514 Completed - Chronic Hepatitis C Clinical Trials

Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy Subjects

Start date: July 15, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of HEC74647 combined with HEC110114 in healthy subjects

NCT ID: NCT04202952 Completed - Chronic Hepatitis C Clinical Trials

The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC110114 Tablets in HCV-infected Subjects

HEC110114
Start date: July 6, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase Ib/IIa, Single Center, Randomized, open, Sofosbuvir-controlled, Multiple Ascending Dose Study to Access the Tolerability,Pharmacokinetics and Pharmacodynamics of HEC110114 Tablets in HCV-infected Subjects

NCT ID: NCT04202081 Completed - Clinical trials for Hepatitis C, Chronic

Voices From the Black Community: Hepatitis C Research Participation

Start date: February 21, 2019
Phase:
Study type: Observational

This is a one-time cross-sectional survey study of approximately 200 self-identified black or African-American patients who have had chronic hepatitis C viral infection (HCV) that will evaluate patients' willingness to participate (WTP) in health/medical research related to HCV and attitudinal factors that might be associated with WTP, such as benefits and barriers to research participation, mistrust of physicians/researchers, health literacy, and knowledge of health/research studies.