Hepatitis C, Chronic, Healthy VolunteerPhase 1NCT01371162
A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C
A Phase 1 study testing RO5428029 in people with Hepatitis C, Chronic, Healthy Volunteer, run by Hoffmann-La Roche at 6 sites in 3 countries.
Trial summary
This 2-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with hepatitis C infection. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Chronic, Healthy Volunteer
- What is being tested?
- RO5428029
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Jun 2011to Dec 2011
- Phase
- Phase 1
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects (Part A) or patients with chronic hepatitis C infection (Part B), 18 to 60 years of age, inclusive
- Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a minimum weight of 45 kg
- Female subjects/patients must be surgically sterile or post-menopausal
- Male subjects/patients and their partners of childbearing potential must use 2 methods of contraception
- For HCV patients:
- Hepatitis C genotype 1 of > 6 months duration at screening
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- HCV RNA quantifiable (Roche COBAS TaqMan HCV Test) at screening
- HCV treatment-naïve (no prior antiviral therapy for chronic hepatitis C with interferon-based therapy)
- Liver biopsy or non-invasive procedure within the past 2 years showing absence of cirrhosis
Who cannot join
- Pregnant or lactating women, and male partners of women who are pregnant or lactating
- Positive test for drugs of abuse
- History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams or 1 unit of alcohol
- History or symptoms of any significant disease or disorder
- History of active malignancy within the last 5 years, except for localized or in situ carcinoma (e.g. basal or squamous cell carcinoma of the skin)
- Positive for hepatitis B or HIV infection, and/ or for HCV for healthy volunteers (Part A)
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- For HCV patients:
- Decompensated liver disease or impaired liver function as defined by any history of ascites, hepatic encephalopathy, hepatocellular carcinoma or bleeding esophageal varices, or prothrombin international normalized ratio (PTINR) >/= 2.0 at screening
- Evidence of cirrhosis and/or incomplete transition to cirrhosis
- Presence or history of non-hepatitis C liver disease
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Poland3 sites
Study site
Chorzów, 41-500
Study site
Warsaw, 01-201
Study site
Wroclaw, 50-349
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of the HCV Nucleoside Inhibitor RO5428029 in Healthy Subjects and in CHC Genotype 1 Infected Patients
This 2-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with hepatitis C infection. Cohorts will be randomized to receive either RO5428029 in ascending doses or placebo for up to 7 days (patients) or up to 14 days (healthy volunteers).
- Conditions
- Hepatitis C, Chronic, Healthy Volunteer
- Being tested
- RO5428029, placebo
- Medical subject headings
- Hepatitis C, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO5428029Drug
Multiple ascending doses
placeboDrug
multiple doses
| Study group | Role | What they receive |
|---|---|---|
| A1 Healthy Volunteers | Experimental | Not described Receives: Drug: RO5428029 |
| A2 | Placebo comparator | Not described Receives: Drug: placebo |
| B1 HCV Infection | Experimental | Not described Receives: Drug: RO5428029 |
| B2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part B: Viral load response: HCV RNA (assessed by Roche COBAS Taqman HCV Test)
Measured: up to 17 days
Parts A + B: Safety: Incidence of adverse events
Measured: up to 24 days
Parts A + B: Pharmacokinetics: Area under the concentration - time curve (AUC)
Measured: up to 24 days
Secondary outcomes (1)
Part B: Viral resistance (viral breakthrough/non-response/partial response) HCV RNA assessed by Roche COBAS Paqman HCV Test
Measured: up to 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, Chronic, Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371162
- Sponsor's protocol ID
- NP25733
- Status last verified
- Nov 2016
- First submitted
- 6 Jun 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of the HCV Nucleoside Inhibitor RO5428029 in Healthy Subjects and in CHC Genotype 1 Infected Patients
- ClinicalTrials.gov ID
- NCT01371162
- Acronym / sponsor ID
- NP25733
- Conditions
- Hepatitis C, Chronic, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 2-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with hepatitis C infection. Cohorts will be randomized to receive either RO5428029 in ascending doses or placebo for up to 7 days (patients) or up to 14 days (healthy volunteers).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 Healthy Volunteers | Experimental | Drug: RO5428029 |
| A2 | Placebo comparator | Drug: placebo |
| B1 HCV Infection | Experimental | Drug: RO5428029 |
| B2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy subjects (Part A) or patients with chronic hepatitis C infection (Part B), 18 to 60 years of age, inclusive
- Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a minimum weight of 45 kg
- Female subjects/patients must be surgically sterile or post-menopausal
- Male subjects/patients and their partners of childbearing potential must use 2 methods of contraception
- For HCV patients:
Key exclusion criteria (10 listed)
- Pregnant or lactating women, and male partners of women who are pregnant or lactating
- Positive test for drugs of abuse
- History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams or 1 unit of alcohol
- History or symptoms of any significant disease or disorder
- History of active malignancy within the last 5 years, except for localized or in situ carcinoma (e.g. basal or squamous cell carcinoma of the skin)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO5428029Multiple ascending doses | Drug | A1 Healthy Volunteers, B1 HCV Infection |
| placebomultiple doses | Drug | A2, B2 |
Primary outcome
Part B: Viral load response: HCV RNA (assessed by Roche COBAS Taqman HCV Test)
Time frame: up to 17 days
Parts A + B: Safety: Incidence of adverse events
Time frame: up to 24 days
Parts A + B: Pharmacokinetics: Area under the concentration - time curve (AUC)
Time frame: up to 24 days
1 secondary outcome
Part B: Viral resistance (viral breakthrough/non-response/partial response) HCV RNA assessed by Roche COBAS Paqman HCV Test
Time frame: up to 17 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO5428029 in people with Hepatitis C, Chronic, Healthy Volunteer, run by Hoffmann-La Roche at 6 sites in 3 countries.
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 9 inclusion and 10 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland, France, Netherlands. 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. Some participants in this study may receive a placebo. 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 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.
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?
Part B: Viral load response: HCV RNA (assessed by Roche COBAS Taqman HCV Test) (time frame: up to 17 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2016.