AzTrials
AzTrials

Chronic Hepatitis CPhase 2HCV-6NCT01949168

A Pilot Study of Boceprevir for the Treatment of Genotype 6 HCV

A Phase 2 study testing Victrelis® (boceprevir) 800mg by mouth, TID (200 mg tablets), Peg-Intron® (peginterferon-α-2b), 1.5ug/kg sc injection and Rebetol® (ribavirin), 1000/1200mg by mouth daily in people with Chronic Hepatitis C, run by St Vincent's Hospital Melbourne at 4 sites in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the antiviral efficacy of Boceprevir-based therapy for the treatment of genotype 6 chronic hepatitis C infection. Boceprevir has recently been approved for the treatment of genotype 1 chronic hepatitis C infection. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Hepatitis C
What is being tested?
Victrelis® (boceprevir) 800mg by mouth, TID (200 mg tablets), Peg-Intron® (peginterferon-α-2b), 1.5ug/kg sc injection and Rebetol® (ribavirin), 1000/1200mg by mouth daily
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
4 sitesAustralia
Study dates
Sep 2013to Sep 2015
Phase
Phase 2
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, at least 18 years of age
  • Asian background
  • HCV treatment-naïve.
  • Chronic HCV infection is defined as one of the following:
  • Positive for anti-HCV antibody (Ab) or HCV RNA at least 6 months before Screening, and positive for HCV RNA and anti-HCVAb at the time of Screening; or
  • Positive for anti-HCV Ab and HCV RNA at the time of Screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease).
Show all 30Show fewer
  • Screening laboratory result indicating HCV genotype 6-infection (HCV-6).
  • Plasma HCV RNA level > 10,000 IU/mL at Screening.
  • IL28B C/C genotype (rs12979860)
  • Per local standard practice, documented results of one of the following:
  • A liver biopsy within 24 months prior to or during screening demonstrating the absence of cirrhosis, e.g., a METAVIR Score of 3 or less, Ishak score of 4 or less; or
  • A screening FibroTest score of ≤ 0.72 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤ 2; or
  • A screening FibroScan result of < 9.6 kPa.
  • Subjects with a non-qualifying Fibrotest/APRI or Fibroscan result may only be enrolled if they have a qualifying liver biopsy preformed within 24 months prior to or during screening.
  • Candidate for PEG/RBV therapy
  • Body mass index (BMI) between 18 and 36 kg/m2
  • Agree to use two highly effective methods of avoiding contraception for the duration of the study and for 7 months after the last dose study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline
  • Provide written informed consent to participate in the study.
  • Subjects must have the following laboratory parameters at Screening:
  • ALT ≤ 10 × the upper limit of normal (ULN)
  • AST ≤ 10 × ULN
  • Hemoglobin ≥ 12 g/dL
  • White blood cell count ≥ 2,500 cells/μL
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
  • Platelets ≥ 90,000/mm3
  • Prothrombin time ≤ 1.5 × ULN
  • Albumin > 3 g/dL
  • Direct (conjugated) bilirubin < ULN
  • Thyroid stimulating hormone (TSH) ≤ ULN
  • Creatinine clearance (CLcr) ≥ 50 mL/min, as calculated by the Cockcroft-Gault equation

Who cannot join

  • Non-genotype 6 HCV infection, or evidence of mixed genotype HCV infection
  • IL28B C/T or T/T polymorphism (rs12979860)
  • Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis, e.g., a Metavir Score of >3 or Ishak score of > 4.
  • Exceed defined thresholds for key laboratory parameters at Screening.
  • Females who are pregnant or plan to become pregnant, or breastfeeding, or males whose partners are pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of study drug.
  • Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human immunodeficiency virus antibody (HIV Ab).
Show all 9Show fewer
  • Diagnosis of autoimmune disease, decompensated liver, disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), hepatocellular carcinoma or other malignancy (with exception of certain skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed
  • Subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. Subjects on stable methadone maintenance treatment for at least 6 months prior to Screening may be included into the study.
  • Use of prohibited concomitant medications two weeks prior to baseline through the end of treatment, as defined by the product label.

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

    John Lubel, MBBS, 61-3 9094 9548

    John Lubel, MBBS

  • Monash Medical Centre

    Clayton, Victoria, 3168

    William Sievert, MBBS, 613 9594 3177, william.sievert@monash.edu

    William Sievert, MBBS

  • St Vincent's Hospital

    Fitzroy, Victoria, 3065

    Swee Lin G Chen Yi Mei, MBBS, 61 3 9288 3580, sweelin.chenyimei@svhm.org.au

    Alexander Thompson, MBBS, 61 3 9288 3580, alexander.thompson@svhm.org.au

  • Western Hospital

    Footscray, Victoria, 3011

    Niranjan JS Arachchi, MBBS, 61-3 83457266

    Niranjan JS Arachchi, MBBS

Other trials in Australia

About this study

Official title: Phase 2a Study of Boceprevir for the Treatment of Genotype 6 Hepatitis C

The purpose of this study is to evaluate the antiviral efficacy of Boceprevir-based therapy for the treatment of genotype 6 chronic hepatitis C infection.

Boceprevir has recently been approved for the treatment of genotype 1 chronic hepatitis C infection. Recent in vitro studies suggest similar efficacy against genotype 6 chronic hepatitis C infection.

The investigators therefore hypothesise that:

  1. Boceprevir is a potent inhibitor of genotype 6 hepatitis C replication in vivo. ii) Boceprevir in combination with pegylated interferon-alpha and ribavirin for 24 weeks will cure a high proportion of patients chronically infected with genotype 6 chronic hepatitis C infection.
Read the detailed description

Genotype 6 HCV (HCV-6) is common in parts of South-East Asia, in particular Vietnam. There is a small but growing population of immigrant patients with chronic HCV-6 in Australia. The current standard-of-care treatment (SOC) for chronic HCV-6 infection is peg-interferon-α (PEG-IFN) and ribavirin (RBV) therapy for 48 weeks. The available data evaluating treatment outcome suggests that SVR rates are intermediate between those of HCV-1 and HCV-2/3. There is a medical need for novel therapies that might increase SVR rates and/or allow shortened treatment duration.

Boceprevir is a novel HCV NS3 protease inhibitor, and boceprevir-based triple therapy has recently been approved for the treatment of HCV-1. Boceprevir also appears to have some antiviral effect against HCV-2 and HCV-3 in vivo. Boceprevir has not been used to treat patients with chronic HCV-6 infection. Recent in vitro data have demonstrated that boceprevir has an antiviral effect against HCV-6.

The investigators are therefore undertaking an investigator-initiated proof-of-concept pilot study of boceprevir-based therapy for the treatment of patients chronically infected with HCV-6.

The study population will consist of a representative group of 30 adult patients who are chronically infected with genotype 6 HCV. All patients will be of Asian background, will be non-cirrhotic, and will carry a "good response" IL28B genotype (C/C for rs12979860). The patients will be recruited from the outpatient clinics of 4 Hepatology units in Melbourne, Australia, represented by the principal and associate investigators.

Being tested
Victrelis® (boceprevir) 800mg by mouth, TID (200 mg tablets), Peg-Intron® (peginterferon-α-2b), 1.5ug/kg sc injection, Rebetol® (ribavirin), 1000/1200mg by mouth daily
Medical subject headings
Hepatitis C, Chronic

What participants receive

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

  • Victrelis® (boceprevir) 800mg by mouth, TID (200 mg tablets)Drug

  • Peg-Intron® (peginterferon-α-2b), 1.5ug/kg sc injectionDrug

  • Rebetol® (ribavirin), 1000/1200mg by mouth dailyDrug

Study groups in NCT01949168
Study groupRoleWhat they receive
Boceprevir triple therapy with 5-day lead inActive comparatorVictrelis® (boceprevir) 800mg by mouth, TID (200 mg tablets) for 5 days, followed by boceprevir plus • Peg-Intron® (peginterferon-α-2b), 1.5ug/kg sc injection plus • Rebetol® (ribavirin), 1000/1200mg, by mouth daily for 24 weeks. In patients who achieve an undetectable plasma HCV RNA level at week 4 of triple therapy (week 5 from baseline), and maintain an undetectable plasma HCV RNA at week 20 of triple therapy (week 21 from baseline), treatment will stop at week 25. Patients who have a detectable plasma HCV RNA at week 4 of triple therapy, but an undetectable plasma HCV RNA at week 20, will continue a with follow-on peginterferon-α-2b plus ribavirin for a further 23 weeks (stopping at week 48).
Receives: Drug: Victrelis® (boceprevir) 800mg by mouth, TID (200 mg tablets); Drug: Peg-Intron® (peginterferon-α-2b), 1.5ug/kg sc injection; Drug: Rebetol® (ribavirin), 1000/1200mg by mouth daily
Boceprevir triple therapyActive comparatorVictrelis® (boceprevir) 800mg by mouth, TID (200 mg tablets) plus Peg-Intron® (peginterferon-α-2b), 1.5ug/kg sc injection and Rebetol® (ribavirin), 1000/1200mg, by mouth daily for 24 weeks. In patients who achieve an undetectable plasma HCV RNA level at week 4 of triple therapy, and maintain an undetectable plasma HCV RNA at week 20 of triple therapy, treatment will stop at week 24. Patients who have a detectable plasma HCV RNA at week 4 of triple therapy, but an undetectable plasma HCV RNA at week 20, will continue a with follow-on peginterferon-α-2b plus ribavirin for a further 24 weeks (stopping at week 48).
Receives: Drug: Victrelis® (boceprevir) 800mg by mouth, TID (200 mg tablets); Drug: Peg-Intron® (peginterferon-α-2b), 1.5ug/kg sc injection; Drug: Rebetol® (ribavirin), 1000/1200mg by mouth daily
Standard of CareActive comparator48 weeks of Peg-Intron® (peginterferon-α-2b), 1.5ug/kg sc injection and Rebetol® (ribavirin), 1000/1200mg by mouth daily (200mg tablets)
Receives: Drug: Peg-Intron® (peginterferon-α-2b), 1.5ug/kg sc injection; Drug: Rebetol® (ribavirin), 1000/1200mg by mouth daily

What is being measured

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

  1. Early viral kinetics

    Determined by plasma HCV RNA quantification at frequent time points - baseline, day 1, 2, 3, 4 and 5

    Measured: Day 5

Secondary outcomes (5)

  1. Rates of virological response

    Percentage of patients with undetectable plasma HCV RNA) at different time-points

    Measured: Day 3, 5, week 2, week 4, week 12 and end of treatment (week 24 or week 48)

  2. Number of patients eligible for Response Guided Therapy

    Patients in Arm A and B randomised to received boceprevir-based triple therapy who achieve an undetectable HCV PCR at week 4 and week 20 are eligible for 24 weeks of therapy, vs. 48 weeks of therapy

    Measured: Week 4 and week 20

  3. Rates of virological breakthrough

    Defined by an increase in HCV RNA > 1 log10 IU/mL from nadir, or HCV RNA increase to > 100 IU/mL in patients who had previously reached an undetectable HCV RNA, and confirmed by 2 consecutive samples < 4 weeks apart.

    Measured: Week 4, week 20, week 24, week 48, week 60

  4. Rates of SVR12 and relapse

    SVR 12 - Number of patients who achieve an undetectable HCV PCR 12-weeks post treatment Relapse - Number of patients who have an undetectable HCV PCR at the end of treatment but detectable HCV PCR 12-weeks post treatment

    Measured: Week 48 and Week 60

  5. Rates of anaemia on treatment

    Measured: Day 0, 1, 2, 3, 4, 5, then monthly up to week 48 of treatment

Timeline

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

  1. First posted24 Sep 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionSep 2015 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01949168
Sponsor's protocol ID
HCV-6 study
Acronym
HCV-6
Status last verified
Sep 2013
First submitted
4 Sep 2013
Last updated
24 Sep 2013
Results posted
No
Data monitoring committee
No

Publications

  • Sievert W, Altraif I, Razavi HA, Abdo A, Ahmed EA, Alomair A, Amarapurkar D, Chen CH, Dou X, El Khayat H, Elshazly M, Esmat G, Guan R, Han KH, Koike K, Largen A, McCaughan G, Mogawer S, Monis A, Nawaz A, Piratvisuth T, Sanai FM, Sharara AI, Sibbel S, Sood A, Suh DJ, Wallace C, Young K, Negro F. A systematic review of hepatitis C virus epidemiology in Asia, Australia and Egypt. Liver Int. 2011 Jul;31 Suppl 2:61-80. doi: 10.1111/j.1478-3231.2011.02540.x.

    PubMed 21651703

  • Dev AT, McCaw R, Sundararajan V, Bowden S, Sievert W. Southeast Asian patients with chronic hepatitis C: the impact of novel genotypes and race on treatment outcome. Hepatology. 2002 Nov;36(5):1259-65. doi: 10.1053/jhep.2002.36781.

    PubMed 12395338

  • Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009 Apr;49(4):1335-74. doi: 10.1002/hep.22759. No abstract available.

    PubMed 19330875

  • Poordad F, McCone J Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS, Jacobson IM, Reddy KR, Goodman ZD, Boparai N, DiNubile MJ, Sniukiene V, Brass CA, Albrecht JK, Bronowicki JP; SPRINT-2 Investigators. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1195-206. doi: 10.1056/NEJMoa1010494.

    PubMed 21449783

  • Bathgate A. Boceprevir for previously treated chronic hepatitis C virus genotype 1 infection. J R Coll Physicians Edinb. 2011 Jun;41(2):122-3. doi: 10.4997/JRCPE.2011.222. No abstract available.

    PubMed 21677916

  • Silva MO, Treitel M, Graham DJ, Curry S, Frontera MJ, McMonagle P, Gupta S, Hughes E, Chase R, Lahser F, Barnard RJ, Howe AY, Howe JA. Antiviral activity of boceprevir monotherapy in treatment-naive subjects with chronic hepatitis C genotype 2/3. J Hepatol. 2013 Jul;59(1):31-7. doi: 10.1016/j.jhep.2013.02.018. Epub 2013 Feb 27.

    PubMed 23454058

  • Ge D, Fellay J, Thompson AJ, Simon JS, Shianna KV, Urban TJ, Heinzen EL, Qiu P, Bertelsen AH, Muir AJ, Sulkowski M, McHutchison JG, Goldstein DB. Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance. Nature. 2009 Sep 17;461(7262):399-401. doi: 10.1038/nature08309. Epub 2009 Aug 16.

    PubMed 19684573

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Victrelis® (boceprevir) 800mg by mouth, TID (200 mg tablets), Peg-Intron® (peginterferon-α-2b), 1.5ug/kg sc injection and Rebetol® (ribavirin), 1000/1200mg by mouth daily in people with Chronic Hepatitis C, run by St Vincent's Hospital Melbourne at 4 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 30 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early viral kinetics (time frame: Day 5). 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 NCT01949168, which also lists 7 linked publications.

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 24 Sep 2013.

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