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dbGaP phs000430 Hepatitis C Antiviral Long-term Treatment Against Cirrhosis (HALT-C) - pht003055.v1.p1

- 12-10-22 - 5 Formulieren, 1 Itemgroep, 5 Data-elementen, 1 Taal

Itemgroep: pht003055

Principal Investigator: Gyongyi Szabo, MD, University of Massachusetts, Worcester, MA, USA MeSH: Hepatitis C,Liver disease,Liver Cirrhosis https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000430 Reprinted from http://www.haltctrial.org/ *Purpose* The *H*epatitis C *A*ntiviral *L*ong-term *T*reatment against *C*irrhosis (HALT-C) Trial is a randomized controlled trial designed to evaluate the safety and efficacy of long-term use of pegylated interferon for the treatment of chronic hepatitis C in patients who failed to respond to previous interferon therapy. The HALT-C Trial was developed to determine whether prolonged interferon therapy altered histological and clinical outcomes in a group of patients who had failed to eradicate hepatitis C virus with previous interferon treatment. *Study Hypotheses* - In patients with chronic hepatitis C and bridging fibrosis who failed to eradicate the virus with previous interferon therapy, long-term treatment with interferon is safe and can prevent progression to cirrhosis. - In patients with cirrhosis secondary to chronic hepatitis C who failed to eradicate the virus with previous interferon therapy, long-term treatment with interferon is safe and can reduce the risks of hepatic decompensation or of hepatocellular carcinoma. *Study Design* 1145 patients with chronic HCV and advanced hepatic fibrosis (Ishak stage 3-6) who failed to respond to previous treatment with interferon were enrolled at 10 clinical centers and entered into a Lead-in phase. They were treated with a combination of pegylated interferon (Pegasys®, Hoffmann-La Roche) 180 µg/week and ribavirin (1000-1200 mg/day) for 24 weeks. Patients who had no detectable HCV-RNA at week 20 continued on combination therapy until week 48. 662 patients who did not clear virus were randomly assigned at week 24 to either continue treatment with pegylated interferon alone (90 µg/week) for an additional 42 months, or to have treatment discontinued. All patients were followed at 3-month intervals following randomization. Liver biopsy was performed at baseline and after 1.5 and 3.5 years of treatment. Because of slower than expected enrollment and the approval by the FDA of peginterferon alfa-2b after the start of the trial, we modified the study protocol in three ways. First, criteria for admission to the trial were liberalized to allow patients to enter the trial with lower platelet and white blood cell counts than had been initially considered safe or tolerable. Second, 151 Lead-in patients and those continuing on therapy after 24 weeks who demonstrated return of viremia during or after their 48-week treatment period (called "Breakthrough" or "Relapse" patients, respectively) were allowed to return to enter the randomized trial. Third, 237 patients treated with peginterferon alfa-2b (or with peginterferon alfa-2a in licensing trials) outside the HALT-C Trial who in other respects met all study criteria, having received the equivalent of Trial Lead-in period therapy, were allowed to enter the long-term trial as "Express" patients. A total 1050 patients were randomized. Those patients who completed Month 48 were offered an "extended follow-up (observation only)" until October 2009. These visits will primarily be to identify outcome events, and to provide information to patients concerning the current status of the trial. Some questionnaires, blood tests, and an ultrasonogram will be performed. *Quarterly (every 3 months)* - Interval history of complications, adverse events - Current medications - Brief physical examination - Laboratory tests: liver panel, CBC, INR, AFP - Child-Pugh Score - Stored serum *Annual* liComplete physical examination/li liUltrasound of liver/li *1.5 years (M24 visit, middle of study)* liLiver biopsy: formalin fixed histology, frozen liver tissue (subset of patients)/li *3.5 years (M48, end of study)* liLiver biopsy: formalin fixed histology, frozen liver tissue (subset of patients)/li liEndoscopy: evaluate esophageal varices and portal hypertension/li *After Month 48* liObservation only (no treatment) to determine clinical outcomes/li liClinic visit every 6 months with current medications, brief PE, liver panel, CBC, AFP, stored/li liSerum/li liUltrasound of liver every 6 months/li *Outcome Variables* Primary outcome variables to be assessed in the two groups of patients include: liDevelopment of cirrhosis on liver biopsy (progression of Ishak fibrosis score by 2 points or more)/li liDevelopment of hepatic decompensation, as shown by:/li liSustained increase in the Child-Turcotte-Pugh score to 7 points or higher/li liVariceal hemorrhage/li liAscites/li liSpontaneous bacterial peritonitis/li liHepatic encephalopathy/li liDevelopment of hepatocellular carcinoma/li liDeath/li Secondary outcomes include quality of life, serious adverse events, events requiring dose reductions, and development of presumed hepatocellular carcinoma.

Eligibility

1 Itemgroep 26 Data-elementen

pht003052.v1.p1

1 Itemgroep 2 Data-elementen

pht003053.v1.p1

1 Itemgroep 5 Data-elementen

pht003054.v1.p1

1 Itemgroep 35 Data-elementen

VX-950HPC3006 NCT01571583 Follow-Up Assignment

- 17-11-21 - 1 Formulier, 1 Itemgroep, 3 Data-elementen, 1 Taal

Itemgroep: Follow-Up Assignment

This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. NCT01571583

Eligibility Hepatitis C NCT02156570

- 27-09-21 - 1 Formulier, 2 Itemgroepen, 16 Data-elementen, 1 Taal

Itemgroepen: Inclusion Criteria, Exclusion Criteria

DAA-based Therapy for Recently Acquired Hepatitis C II (DAA = Directly Acting Antiviral); ODM derived from: https://clinicaltrials.gov/show/NCT02156570

Eligibility Hepatitis C Virus NCT02265237

- 27-09-21 - 1 Formulier, 2 Itemgroepen, 13 Data-elementen, 1 Taal

Itemgroepen: Inclusion Criteria, Exclusion Criteria

A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1); ODM derived from: https://clinicaltrials.gov/show/NCT02265237

Eligibility Hepatitis C, Chronic NCT01770483

- 27-09-21 - 1 Formulier, 2 Itemgroepen, 12 Data-elementen, 1 Taal

Itemgroepen: Inclusion Criteria, Exclusion Criteria

The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01770483

Eligibility Hepatitis C, Chronic NCT01591460

- 20-09-21 - 1 Formulier, 2 Itemgroepen, 19 Data-elementen, 1 Taal

Itemgroepen: Inclusion Criteria, Exclusion Criteria

A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT01591460

Eligibility Hepatitis C, Chronic NCT01447420

- 20-09-21 - 1 Formulier, 2 Itemgroepen, 15 Data-elementen, 1 Taal

Itemgroepen: Inclusion Criteria, Exclusion Criteria

A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin); ODM derived from: https://clinicaltrials.gov/show/NCT01447420

Eligibility Hepatitis C, Chronic NCT01483742

- 20-09-21 - 1 Formulier, 2 Itemgroepen, 10 Data-elementen, 1 Taal

Itemgroepen: Inclusion Criteria, Exclusion Criteria

A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis; ODM derived from: https://clinicaltrials.gov/show/NCT01483742

Eligibility Hepatitis C NCT00814606

- 20-09-21 - 1 Formulier, 2 Itemgroepen, 17 Data-elementen, 1 Taal

Itemgroepen: Inclusion Criteria, Exclusion Criteria

A Pilot Trial to Determine the Safety and Efficacy of Fluvastatin in Previous Partial Responders to Pegylated Interferon and Ribivirin in Patients With Genotype 1 Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00814606

Eligibility Hepatitis C, Chronic NCT01296971

- 20-09-21 - 1 Formulier, 2 Itemgroepen, 11 Data-elementen, 1 Taal

Itemgroepen: Inclusion Criteria, Exclusion Criteria

A Study of the Safety of Individualized Combination Therapy With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C (MASTER); ODM derived from: https://clinicaltrials.gov/show/NCT01296971

Eligibility Hepatitis C NCT01415141

- 20-09-21 - 1 Formulier, 2 Itemgroepen, 22 Data-elementen, 1 Taal

Itemgroepen: Inclusion Criteria, Exclusion Criteria

Peginterferon and Ribavirin, With or Without Telaprevir, for Genotype 1 Hepatitis C and IL28B CC Polymorphism; ODM derived from: https://clinicaltrials.gov/show/NCT01415141

Eligibility Hepatitis C NCT01937728

- 20-09-21 - 1 Formulier, 2 Itemgroepen, 16 Data-elementen, 1 Taal

Itemgroepen: Inclusion Criteria, Exclusion Criteria

Tailored Regimens of PEGASYS® and Ribavirin for Genotype 1 Chronic Hepatitis C Patients Trial (TARGET-1); ODM derived from: https://clinicaltrials.gov/show/NCT01937728

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