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Hepatitis C, ChronicPhase 1/2NCT00389298

A Proof-of-concept Study of VCH-759 for the Treatment of Hepatitis C-infection.

A Phase 1/2 study testing VCH-759 (BCH-27759) in people with Hepatitis C, Chronic, run by Vertex Pharmaceuticals Incorporated at 4 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether a 10-day course of therapy with orally administered VCH-759 given at 400-mg, 600-mg or 800-mg three times daily can effectively reduce the amount of circulating virus (i.e., viral load) in patients with early-stage chronic hepatitis C-infection. Read more about this study

Who is it for?
Ages 18 to 60 years, men only
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
VCH-759 (BCH-27759)
How many people
36 participants
Where
4 sitesCanada
Study dates
Oct 2006to Jun 2007
Phase
Phase 1/2
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 60 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 18 to 60 years of age
  • Body mass index (BMI) ≤ 30
  • No evidence of cirrhosis or have liver fibrosis corresponding to Metavir Stages 0 to 3
  • Subject's liver disease is stable (i.e., stable ALT and AST)
  • Serologic evidence of chronic hepatitis C-infection (anti-HCV in serum)
  • HCV plasma RNA >1 x 105 (copies/mL) at baseline
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  • HCV Genotype 1
  • Documented liver biopsy within the last 5 years
  • Hemoglobin > or =11.0 g/dL for females and > or =12.0 g/dL for males
  • Platelet count higher than 50
  • Treatment-naïve for HCV-infection
  • Normal calculated creatinine clearance using the Modification of Diet in Renal Disease (MDRD) study formula
  • Normal thyroid function
  • Female subjects, cannot be pregnant or breastfeeding and must be either postmenopausal, surgically sterile, abstinent, or using two proven methods of birth control
  • Sexually active male subjects, must be practicing acceptable methods of contraception (vasectomy, use of condom plus spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period
  • Negative serum ß-HCG (females only)
  • Provided informed consent
  • Willing to comply with all study requirements

Who cannot join

  • Participating in any other clinical studies or have participated in another clinical trial within the last 30 days
  • Have relapsed following previous therapy for hepatitis C-infection
  • Actively taking hard illicit drugs (such as cocaine, phencyclidine, or crack within 6 months before screening visit)
  • Evidence of liver cirrhosis
  • Child-Pugh score >5
  • Any cause of liver disease other than chronic hepatitis C-infection, including but not limited to:
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  • Hemochromatosis
  • Alpha-1 antitrypsin deficiency
  • Wilson's disease
  • Autoimmune hepatitis
  • Autoimmune thyroidopathy
  • Alcoholic liver disease
  • Nonalcoholic steatohepatitis
  • Drug-related liver disease
  • Active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma)
  • Organ transplants, except for corneal or hair transplant
  • Clinically significant electrocardiogram abnormalities and/or cardiovascular dysfunction within 6 previous months (e.g., angina, congestive heart failure, recent myocardial infarction, significant arrhythmia, or prolongation of QTc interval)
  • Significant renal, pulmonary, gastrointestinal absorption, or neurological diseases, or neoplasia
  • Type 1 diabetes, or Type II diabetes being treated with oral hypoglycemic agents
  • Co-infection with hepatitis B (HBV) and/or human immunodeficiency (HIV) virus
  • Taking the following concomitant medications:
  • Drugs of abuse (as outlined above)
  • Systemic antibiotic, antiviral, or antifungal treatments
  • All cytostatic or oncolytic medications
  • Drugs that are under routine therapeutic drug monitoring such as antiepileptic (anti-seizure) drugs, digoxin, coumadin and others
  • All lipid lowering agents
  • Drugs that influence hemostasis
  • Thyreostatic drugs from the group of thionamids
  • The following antihistaminics: terfenadine, cyproheptadine and promethazine
  • Tricyclic antidepressants
  • Antipsychotic drugs (neuroleptics)
  • Lithium
  • Thalidomide
  • Other condition that, in the investigator's opinion, could determine that the subject's participation in the study is not indicated or could interfere with the subject's participation in and completion of study
  • Randomized to this study more than once

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Foothills Medical Centre

    Calgary, Alberta, T2N 4N1

  • McGill University Hospital Centre (MUHC) - Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

  • Ottawa Hospital; General Campus

    Ottawa, Ontario, K1H 8L6

  • Liver and Intestinal Research Centre

    Vancouver, British Columbia, V5Z 1H2

Other trials in Canada

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-blinded, and Placebo-controlled Study of the Antiviral Activity, Safety and Pharmacokinetics of VCH-759 in Subjects With Chronic Hepatitis C-infection.

The purpose of this study is to determine whether a 10-day course of therapy with orally administered VCH-759 given at 400-mg, 600-mg or 800-mg three times daily can effectively reduce the amount of circulating virus (i.e., viral load) in patients with early-stage chronic hepatitis C-infection. This study will also evaluate the safety and tolerability of treatment with VCH-759. Blood samples will also be taken to measure the levels of VCH-759 present in plasma at various time points during the treatment period.

Read the detailed description

The primary objectives of this trial are to assess the antiviral activity, safety, and tolerability of VCH-759 monotherapy in adult subjects with early-stage chronic HCV-infection.

In addition, the pharmacokinetic (PK) profile of VCH-759 at steady state in HCV-infected adults and the relationship between VCH-759 plasma levels and corresponding HCV RNA reduction with the administered dosages of VCH-759 in adults will also be investigated. The kinetics of plasma HCV RNA during treatment for up to ten (10) days with VCH-759 and following discontinuation of therapy will also be studied.

This is a randomized, double-blinded, placebo-controlled study in which subjects will be assigned to receive treatment with one of the following oral dosages of VCH-759: 400 mg t.i.d., 600 mg t.i.d., and 800 mg t.i.d., or placebo; enrollment into the three cohorts will occur sequentially. Within each cohort, subjects will be randomized to a treatment: placebo ratio of 3:1 for a total of 12 subjects per cohort; subjects will be randomized in blocks of 4. The decision to continue dosing within a cohort will be determined by an independent review of all safety data up to and including Day 11 for the first 4 subjects within that dose cohort; this review will be conducted by a qualified medical specialist, in conjunction with the sponsor and medical monitor. The decision to proceed to the next cohort will be decided by an independent review of Day 11 safety data for all 12 subjects in the previous cohort. Eligible subjects will receive study medication three times daily for 10 days and will return to the study center for follow-up assessments on Day 11, Day 17, and Day 24.

Being tested
VCH-759 (BCH-27759)
Keywords
Chronic hepatitis C, Viral kinetics, Phase II, Pharmacokinetics (PK), Safety and tolerability
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.

  • VCH-759 (BCH-27759)Drug

What is being measured

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

  1. Change in baseline HCV plasma RNA (i.e., viral load) at Day 11.

Secondary outcomes (1)

  1. The change in plasma HCV RNA (i.e., viral load) over the treatment period (Days 1 to 10 will also be assessed.

Timeline

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

  1. First posted18 Oct 2006 (estimated)
  2. Study startOct 2006
  3. Study completionJun 2007

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00389298
Sponsor's protocol ID
VCH759-201
Status last verified
Sep 2009
First submitted
16 Oct 2006
Last updated
24 Sep 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VCH-759 (BCH-27759) in people with Hepatitis C, Chronic, run by Vertex Pharmaceuticals Incorporated at 4 sites in Canada.

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 18 inclusion and 35 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: finished, as of the sponsor's last update on 24 Sep 2009. 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 Canada. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in baseline HCV plasma RNA (i.e., viral load) at Day 11.. 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 NCT00389298.

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 2009.

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