Response Guided Treatment With Direct Acting Anti-Viral Medications for Chronic HCV Infection

NCT03603327 | Completed

• 1 other identifier: 0285-17-SOR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the efficacy and safety of direct acting anti-viral agents (DAA) therapy in chronically infected Hepatitis C Virus (HCV) patients using an individualized response guided therapy (RGT) model.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (2)

• Rate of sustained virological response (SVR)

  Sustained virological response (SVR), defined as an HCV RNA level of less than 10 IU/mL and measured by the Cepheid GeneXpert essay.

  at 12 weeks after the end of treatment in all patients who received at least 4 weeks of therapy with any of the 5 optional drug regimens.

• The percentage of patients in whom duration of treatment with DAA can be shortened to less than 12 weeks.

  through study completion, an average of 1 year

Study Arms (1)

Treatment

OTHER

All subjects will receive a standard of care treatment- Direct acting anti-viral agents Drugs

Drug: Direct acting anti-viral agents

Interventions

Direct acting anti-viral agents DRUG

Standard of care for Hepatitis C treatment

Also known as: Treatment

Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Clalit insured patients
• Female and male over the age of 18
• Capacity to provide written informed consent
• HCV RNA Viral Load (VL) larger than 105 IU/mL at screening and on at least one other occasion 6 months or more prior to the most recent HCV RNA test result.
• HCV genotypes 1a, 1b, 2, 3 or 4
• Liver fibrosis stage 0-4 as determined by one of the following methods performed within 2 years prior to the screening visit:
• Fibrotest
• Transient elastography
• Liver biopsy using the METAVIR scoring system.
• Patients must have the following laboratory parameters within 3 months of screening
• ALT and AST ≤ x10 the upper limit of normal (ULN)
• Direct bilirubin ≤ 1.5 the ULN
• Platelet count ≥70,000
• Hemoglobin ≥10 mg/dL

You may not qualify if:

• Current or past history of any of the following:
• Clinically significant illness (other than HCV) or any other medical disorder that may interfere with patient's assessment, treatment or compliance with the protocol. Examples include congestive heart disease with moderate to severe left ventricular function and chronic obstructive pulmonary disease requiring chronic corticosteroid therapy.
• Clinical evidence of decompensated liver disease (e.g. ascites, bleeding esophageal varices, spontaneous bacterial peritonitis, encephalopathy or hepatorenal syndrome.)
• Child Pugh score higher than 6
• Gastrointestinal disorder or post-operative condition that may interfere with the absorption of the study drug.
• Solid organ transplantation
• 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.) Patients under the evaluation for possible malignancy are not eligible.
• Any prior treatment with a DAA (protease inhibitors, NS5A inhibitors, NS5B polymerase inhibitors/non-nucleoside polymerase inhibitors)
• Use of anti-viral medications within 30 days of screening.
• Chronic use of systemically administered immunosuppressive/immune- modulating medications
• Clinically relevant substance abuse within 6 months of enrollment. Patient with prior history of drug addiction who are currently maintained on a stable dose of opiate substitutes (naloxone) will be allowed to participate in the study if they can provide documentation of repeated negative toxicology screens from the 6 months prior to screening.
• Participating in clinical trial 30 days before screening.

Sponsors & Collaborators

• Soroka University Medical Center: lead
• Loyola University, Harel Dahari, PhD, mathematical modeling support: collaborator

Study Sites (2)

Soroka UMC

Beersheba, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Related Publications (1)

• Etzion O, Dahari H, Yardeni D, Issachar A, Nevo-Shor A, Cohen-Naftaly M, Ashur Y, Uprichard SL, Arbib OS, Munteanu D, Braun M, Cotler SJ, Abufreha N, Keren-Naus A, Shemer-Avni Y, Mor O, Murad J, Novack V, Shlomai A. Response guided therapy for reducing duration of direct acting antivirals in chronic hepatitis C infected patients: a Pilot study. Sci Rep. 2020 Oct 20;10(1):17820. doi: 10.1038/s41598-020-74568-x.

  PMID: 33082372 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Ohad Etzion, MD

  Soroka UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastroantrology

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 27, 2018
• Study Start: February 25, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

IL (2)