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Hepatocellular CarcinomaPhase 3HATCHeTNCT04546802

HepATocellular Cancer Hcv Therapy Study

A Phase 3 study testing Elbasvir / Grazoprevir Oral Tablet in people with Hepatocellular Carcinoma and Hepatoma, run by Bayside Health.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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]. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Elbasvir / Grazoprevir Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2019to Jun 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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

About this study

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

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].

Read the 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..
Being tested
Elbasvir / Grazoprevir Oral Tablet
Keywords
hepatitis C, Elbasvir/grazoprevir, Hepatocellular carcinoma
Medical subject headings
Carcinoma, Hepatocellular, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elbasvir / Grazoprevir Oral TabletDrug

    Elbasvir / Grazoprevir

Study groups in NCT04546802
Study groupRoleWhat they receive
Immediate treatmentActive comparatorThis group will undergo immediate treatment of the HCV once HCC complete response (CR) has been confirmed
Receives: Drug: Elbasvir / Grazoprevir Oral Tablet
Delayed treatmentActive comparatorThis group will delay commencement of the HCV treatment until 6 months after HCC complete response (CR) has been confirmed
Receives: Drug: Elbasvir / Grazoprevir Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Viral eradication

    Eradication of Hepatitis C virus determined by undetectable viral load

    Measured: 12 weeks

Secondary outcomes (5)

  1. HCC recurrence rate following HCC treatment

    impact of DAA therapy on 6 and 12 month HCC recurrence rate following HCC treatment

    Measured: 6 and 12 month

  2. Recurrence free survival

    Recurrence free survival

    Measured: 5 years

  3. Disease free survival

    Disease free survival

    Measured: 5 years

  4. Time to HCC recurrence / progression

    Time to HCC recurrence / progression

    Measured: 5 years

  5. Adverse events

    Safety and tolerability of Elbasvir/grazoprevir determined by adverse events

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2020
  2. Study startSep 2019 (estimated)
  3. Primary completionJun 2021 (estimated)
  4. Study completionJun 2023 (estimated)

Why it stopped: Recruitment will be too difficult due to available PBS funded treatment and recent Australian clinical guidelines will conflict with the premise of the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04546802
Sponsor's protocol ID
288/18
Acronym
HATCHeT
Status last verified
Sep 2020
First submitted
14 Oct 2018
Last updated
14 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Elbasvir / Grazoprevir Oral Tablet in people with Hepatocellular Carcinoma and Hepatoma, run by Bayside Health.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Viral eradication (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04546802.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.

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