HepATocellular Cancer Hcv Therapy Study

NCT04546802 | Withdrawn Phase 3 DMC

• 1 other identifier: 288/18
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Subjects with Hepatitis C Virus (HCV) infection, genotype 1 or 4 and with hepatocellular carcinoma (HCC) and a complete response to HCC therapy will be randomised to immediate or delayed (6 months) HCV therapy with Elbasvir (MK-8742) and Grazoprevir (MK-5172) \[EBR/GZR\].

Conditions

Hepatocellular Carcinoma; Hepatoma; Liver Cell Carcinoma; Hepatitis C

Keywords

hepatitis C; Elbasvir/grazoprevir; Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Viral eradication

  Eradication of Hepatitis C virus determined by undetectable viral load

  12 weeks

Secondary Outcomes (5)

• HCC recurrence rate following HCC treatment

  6 and 12 month

• Recurrence free survival

  5 years

• Disease free survival

  5 years

• Time to HCC recurrence / progression

  5 years

• Adverse events

  Up to 5 years

Other Outcomes (1)

• Overall survival

  Up to 5 years

Study Arms (2)

Immediate treatment

ACTIVE COMPARATOR

This group will undergo immediate treatment of the HCV once HCC complete response (CR) has been confirmed

Drug: Elbasvir / Grazoprevir Oral Tablet

Delayed treatment

ACTIVE COMPARATOR

This group will delay commencement of the HCV treatment until 6 months after HCC complete response (CR) has been confirmed

Drug: Elbasvir / Grazoprevir Oral Tablet

Interventions

Elbasvir / Grazoprevir Oral Tablet DRUG

Elbasvir / Grazoprevir

Delayed treatment; Immediate treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hepatitis C diagnosed as the HCV RNA (≥ 10,000 IU/mL in peripheral blood) at the time of screening
• Have documented chronic HCV GT1 or GT4, (with no evidence of nontypeable or mixed genotype) infection
• HCC diagnosed on the basis of histology or according to AASLD radiological criteria,
• Written informed consent granted prior to initiation of any study-specific screening procedures
• Patients aged 18 to 70 years-old;
• Child-Pugh ≤≤ A6
• BCLC stage 0, A HCC or no detectable HCC in a patient who has undergone a curative form of treatment (liver transplantation, surgical resection of local ablative therapy with curative intent) OR BCLC-B disease but clinically stable with non-evidence of disease progression as demonstrated by either Triphasic CT or contrast MRI at least 3 months after the last HCC treatment.

You may not qualify if:

• Enrolment in other investigation / experimental therapies
• Prior or current use of Sorafenib or other systemic chemotherapy
• Life expectancy \< 12 months (unless transplantation eligible)
• Unable to provide informed consent
• Previous or concurrent cancer that is distinct from HCC in primary site or histology, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated \> 3 years prior to enrollment is permitted.
• Any condition that in the opinion of the investigator would impair participation in the trial.
• Coinfected with human immunodeficiency virus (HIV) infection or Hepatitis B virus (e.g. HBsAg positive).
• History of congestive heart failure defined as Class II to IV per New York Heart Association (NYHA) classification within 6 months prior to study entry; active coronary artery disease (CAD); clinically significant bradycardia or other uncontrolled, cardiac arrhythmia defined as ≥ Grade 3 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, or uncontrolled hypertension; myocardial infarction occurring within 6 months prior to study entry (myocardial infarction occurring \> 6 months prior to study entry is permitted)
• Active clinically serious infections defined as ≥ Grade 3 according to NCI CTCAE, version 4.03 6. Any medical, psychological, or social conditions, particularly if unstable, including substance abuse, that may, in the opinion of the Investigator, interfere with the subject's safety or participation in the study, protocol compliance, or evaluation of the study results
• Pregnancy or breast-feeding
• Inability to swallow oral medications
• Clinically significant gastrointestinal bleeding occurring ≤ 3 months prior to study entry or Large gastric-esophageal varices (larger than 5 cm) or previous history of gastric-esophageal bleeding due to varices.
• Creatinine Clearance \<50 mL/min
• Hemoglobin \<11 g/dL for females and \<12 g/dL for males
• Platelets \<75 x 103/μL

Sponsors & Collaborators

• Bayside Health: lead
• Merck Sharp & Dohme LLC: collaborator
• Austin Hospital, Melbourne Australia: collaborator

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hepatitis C

Interventions

elbasvir-grazoprevir drug combination

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis

Study Officials

• William kemp, MBBSFRACPPhD

  The Alfred

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager Research and Ethics Department

Study Record Dates

• First Submitted: October 14, 2018
• First Posted: September 14, 2020
• Study Start: September 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2023
• Last Updated: September 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share