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HepATocellular Cancer Hcv Therapy Study (HATCHeT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04546802
Recruitment Status : Withdrawn (Recruitment will be too difficult due to available PBS funded treatment and recent Australian clinical guidelines will conflict with the premise of the study.)
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Collaborators:
Merck Sharp & Dohme LLC
Austin Hospital, Melbourne Australia
Information provided by (Responsible Party):
Ms. Rowan Frew, Bayside Health

Study Description
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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].

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Hepatoma Liver Cell Carcinoma Hepatitis C Drug: Elbasvir / Grazoprevir Oral Tablet Phase 3

Detailed Description:

Two cohorts (A and B) of patients with chronic HCV infection will be enrolled. Patients will be eligible for enrollment if they fulfill the study inclusion and exclusion criteria and have achieved a complete tumour response (CR) 3 months (+/- 14 days) following HCC treatment

  • Cohort A: Patients with Barcelona Clinic Liver Cancer (BCLC) stage 0 or A HCC who have received curative therapy defined as either; liver transplantation, surgical resection or local ablation with curative intent and attained a radiologically confirmed CR. (N=50)
  • Cohort B: Patients who are non-eligible for curative therapy but have attained a radiologically confirmed CR. post embolization or ablative therapy and have chronic HCV infection. (N=50) Given the existing uncertainty regarding the impact of direct acting antiviral (DAA) therapy on HCC recurrence, study participants will be randomized to receive DAA treatment as "immediate" ie upon study enrollment or "delayed" ie treatment commenced ≥ 6months following documentation of complete response based on radiological assessment indicating no residual arterial enhancing disease..
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Trial to Study the Efficacy and Safety of MK-5172 and MK-8742 +/- Ribavirin (RBV) in the Treatment of Hepatitis C G1 and 4, in Patients Eligible for Liver Transplant (HCC) or Curative Therapy or Clinically Stable Disease Post Local Resection, Embolization or Ablative Therapy
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Immediate treatment
This group will undergo immediate treatment of the HCV once HCC complete response (CR) has been confirmed
 Drug: Elbasvir / Grazoprevir Oral Tablet
Elbasvir / Grazoprevir
Active Comparator: Delayed treatment
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
Elbasvir / Grazoprevir


Outcome Measures
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Primary Outcome Measures :
  1. Viral eradication [ Time Frame: 12 weeks ]
    Eradication of Hepatitis C virus determined by undetectable viral load


Secondary Outcome Measures :
  1. HCC recurrence rate following HCC treatment [ Time Frame: 6 and 12 month ]
    impact of DAA therapy on 6 and 12 month HCC recurrence rate following HCC treatment

  2. Recurrence free survival [ Time Frame: 5 years ]
    Recurrence free survival

  3. Disease free survival [ Time Frame: 5 years ]
    Disease free survival

  4. Time to HCC recurrence / progression [ Time Frame: 5 years ]
    Time to HCC recurrence / progression

  5. Adverse events [ Time Frame: Up to 5 years ]
    Safety and tolerability of Elbasvir/grazoprevir determined by adverse events


Other Outcome Measures:
  1. Overall survival [ Time Frame: Up to 5 years ]
    Overall survival determined by proportion surviving


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hepatitis C diagnosed as the HCV RNA (≥ 10,000 IU/mL in peripheral blood) at the time of screening
  • Genotype inclusions
  • 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.

Exclusion Criteria:

  • 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
  • Concomitant interferon therapy or therapies for active Hepatitis C Virus (HCV) infection. Prior interferon and/or ribavirin therapy is not a contraindication to enrolment however previous treatment with direct acting antiviral treatment is an exclusion
  • 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.

  • Fulfills exclusion criteria on biochemistry results:

    • Creatinine Clearance <50 mL/min
    • Hemoglobin <11 g/dL for females and <12 g/dL for males
    • Platelets <75 x 103/μL
    • Serum Albumin < 3.0 g/dL
    • INR >1.7
    • HbA1c >10%
    • ALT >10XULN, AST >10XULNtherapy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04546802


Sponsors and Collaborators
Bayside Health
Merck Sharp & Dohme LLC
Austin Hospital, Melbourne Australia
Investigators
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Principal Investigator: William kemp, MBBSFRACPPhD The Alfred
More Information
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Responsible Party: Ms. Rowan Frew, Manager Research and Ethics Department, Bayside Health
ClinicalTrials.gov Identifier: NCT04546802    
Other Study ID Numbers: 288/18
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ms. Rowan Frew, Bayside Health:
hepatitis C
Elbasvir/grazoprevir
Hepatocellular carcinoma
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Carcinoma
Carcinoma, Hepatocellular
Hepatitis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Grazoprevir
Antiviral Agents
Anti-Infective Agents