AzTrials
AzTrials

Hepatitis C, ChronicPhase 4HEPCOG-IINCT02292966

Impact of HCV Treatment on Neurocognitive Functions and Brain Metabolism

A Phase 4 study testing DCV/ASV/BCV in people with Hepatitis C, Chronic, run by Kirby Institute at 2 sites in Australia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The purpose of this study is to examine whether neurocognitive impairments experienced by patients with chronic hepatitis C virus (HCV) infection can be reversed by treating HCV, with a new combination of direct acting antiviral drugs (daclatasvir (DCV), asunaprevir (ASV) and beclabuvir (BCV)). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
DCV/ASV/BCV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesAustralia
Study dates
Jul 2015to Jun 2016
Phase
Phase 4
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 65 years
  • Chronic HCV infection as documented by positive HCV RNA at screening and positive HCV RNA or anti-HCV antibody at least 6 months prior to screening
  • HCV genotype 1 - mixed subtype, indeterminate subtype or other variants of genotype 1 are permissible
  • Non-advanced cirrhotic defined as FibroScan ≤9.6 kPA at screening
  • HCV treatment naïve
  • Seronegative for HIV and HBsAg
Show all 12Show fewer
  • HCV RNA level of ≥104 IU/mL (10,000 IU/mL)
  • Body Mass Index (BMI) between 18 and 35 kg/m2
  • Women of childbearing potential (WOCBP) must:
  • Have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/mL or equivalent units of HCG) within 24 hours prior to the start of study drug ii. Not be breastfeeding iii. Agree to follow instructions for methods of contraception for the duration of the treatment and for five weeks post-treatment completion
  • Men who are sexually active with WOCBP must agree to follow instructions for methods of contraception for the duration of the treatment and for 14 weeks post-treatment completion
  • Sufficient proficiency in English to complete the neurocognitive assessment, as judged by the investigator

Who cannot join

  • Target disease
  • Infected with HCV other than genotype 1
  • Medical history and concurrent diseases
  • Current hazardous consumption of alcohol, defined by an AUDIT-C score ≥4 for men and ≥3 for women
  • Illicit substance use, identified by urinary drug test at screening
  • Past history of non HCV-related CNS disorder, including seizures and traumatic brain injury
Show all 38Show fewer
  • Currently on an SSRI or other neuropsychiatric therapy
  • Liver or any other organ transplant other than cornea and hair
  • Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrolment
  • Evidence of a medical condition contributing to chronic liver disease other than HCV (such, but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcohol liver disease)
  • Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug (subjects who have cholecystectomy are permitted to enter the study)
  • Known history of coagulopathy including, but not limited to, hemophilia
  • Uncontrolled diabetes defined as HbA1c >7% at screening
  • Confirmed, uncontrolled hypertension (any screening systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg should be excluded unless discussed with the study medical monitor)
  • Inability to tolerate oral medication
  • Poor venous access
  • Any other medical, psychiatric and/or social reason which, in the opinion of the investigator would make the subject inappropriate for the study
  • Physical and Laboratory Test Findings
  • ALT ≥ 5 x ULN
  • Total Bilirubin ≥ 34 µmol/L (≥ 2 mg/dl), unless subject has documented history of Gilbert's disease
  • INR ≥ 1.3
  • Albumin < 3.5 g/dL (35g/L)
  • Platelets < 100 x 109 cells/L
  • ANC < 0.75 x 109 cells/L
  • Hemoglobin < 10 g/dL (100g/L)
  • Creatinine clearance (CrCL) ≤ 50 mL/min
  • Alpha fetoprotein (AFP) > 50ng/mL
  • QTcF or QTcB > 580mSec
  • Positive HBsAg, HIV-1 or HIV-2 Ab
  • Allergies and Adverse Drug Reaction
  • History of hypersensitivity to drugs with a similar biochemical structure to DCV, ASV or BCV
  • Any other criteria or know contraindication that would exclude the subject from receiving DCV, ASV or BCV Prohibited treatments and/or Therapies
  • Exposure to any investigational drug or placebo within 4 weeks of study drug administration
  • Refer to 5.5 for prohibited and/or restricted treatments during and post-treatment Sex and reproductive status
  • Males and females who do not or are unable to meet the requirements outlined in Inclusion Criterias 9 and 10
  • Other Exclusion Criteria
  • Prisoners or subjects who are involuntarily incarcerated
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infection disease) illness

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

  • St Vincent's Hospital

    Sydney, New South Wales, 2010

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official title: Impact of HCV Eradication on Neurocognitive Functions and CNS Metabolism: a Trial of Daclatasvir, Asunaprevir and Beclabuvir for Patients With HCV Genotype 1 Infection

The purpose of this study is to examine whether neurocognitive impairments experienced by patients with chronic hepatitis C virus (HCV) infection can be reversed by treating HCV, with a new combination of direct acting antiviral drugs (daclatasvir (DCV), asunaprevir (ASV) and beclabuvir (BCV)). The study will assess the effect of HCV on the central nervous system (CNS) by assessing neurocognitive function and brain injury prior to treatment, and comparing it to the end of treatment, and 4, 12 and 24 weeks after treatment.

Read the detailed description

This study will evaluate the effect of DCV/ASV/BCV on neurocognitive functioning and brain metabolite concentrations in the frontal white matter and the basal ganglia in people with chronic HCV genotype 1 infection, through a comparison of baseline and post-treatment parameters.

This is an open label single arm multi-centre study. All participants will each receive daclatasvir (30mg), asunaprevir (200mg) and beclabuvir (75mg) in a fixed-dose combination oral tablet for twice daily administration with food.

Duration of treatment will be 12 weeks for all subjects followed by 24 weeks of observational follow-up.

Being tested
DCV/ASV/BCV
Keywords
Hepatitis C, Hepatitis, Asunaprevir, Daclatasvir, Beclabuvir, Neurocognitive function, Brain metabolites, Direct acting antiviral therapy
Medical subject headings
Hepatitis C, Chronic, Hepatitis C, Hepatitis

What participants receive

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

  • DCV/ASV/BCVDrug

    Also called Daclatasvir, Asunaprevir, Beclabuvir

    Each participant will each receive daclatasvir (30mg), asunaprevir (200mg) and beclabuvir (75mg) in a fixed-dose combination oral tablet for twice daily administration with food.

Study groups in NCT02292966
Study groupRoleWhat they receive
Hepatitis C treatmentExperimental12 weeks of DCV/ASV/BCV therapy.
Receives: Drug: DCV/ASV/BCV

What is being measured

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

  1. Neurocognitive functioning

    Mean change in neurocognitive functioning (global z-score representing overall neurocognitive performance across CogState, pegboard and colours trails)

    Measured: 36 weeks

  2. Brain metabolite concentrations

    Mean change in five absolute metabolite concentrations (NAA,Cho, Cr, mlo, glx)

    Measured: 36 weeks

Secondary outcomes (8)

  1. Neurocognitive functioning

    Mean change in neurocognitive functioning (global z-score representing overall neurocognitive performance across CogState, pegboard and colours trails)

    Measured: 12 and 24 weeks

  2. NAA metabolite concentration in the brain

    Measured: 12 and 24 weeks

  3. Cho metabolite concentration in the brain

    Measured: 12 and 24 weeks

  4. Cr metabolite concentration in the brain

    Measured: 12 and 24 weeks

  5. MLO metabolite concentration in the brain

    Measured: 12 and 24 weeks

  6. Glx metabolite concentration in the brain

    Measured: 12 and 24 weeks

  7. Change in neurocognitive functioning compared between subjects with and without sustained virological response (SVR)

    Mean change in neurocognitive functioning (global z-score representing overall neurocognitive performance across CogState, pegboard and colours trails)

    Measured: 24 weeks

  8. Change in brain metabolite concentrations compared between subjects with and without sustained virological response (SVR)

    Mean change in absolute metabolite concentrations (NAA,Cho, Cr, mlo, glx)

    Measured: 24 weeks

Timeline

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

  1. First posted18 Nov 2014 (estimated)
  2. Study startJul 2015
  3. Primary completionJun 2016 (estimated)
  4. Study completionJun 2016 (estimated)

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02292966
Sponsor's protocol ID
VHCRP1304
Acronym
HEPCOG-II
Status last verified
Jun 2016
First submitted
25 Sep 2014
Last updated
3 Jun 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing DCV/ASV/BCV in people with Hepatitis C, Chronic, run by Kirby Institute at 2 sites in Australia.

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 12 inclusion and 38 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 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Neurocognitive functioning (time frame: 36 weeks). The study lists 2 primary outcomes in all. 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 NCT02292966.

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 3 Jun 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in