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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00382798




Registration number
NCT00382798
Ethics application status
Date submitted
28/09/2006
Date registered
2/10/2006
Date last updated
27/04/2009

Titles & IDs
Public title
Adaptive Phase I HCV Study With Nucleoside Analogue, in Combination With Interferon and Ribavirin
Scientific title
A Multiple-Center, Observer-Blinded, Randomized, Placebo-Controlled, Single & Multiple Ascending Dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, & Food Effect of RO5024048 in Healthy Volunteers & in Patients With Chronic HCV Infection
Secondary ID [1] 0 0
P7081-5101
Universal Trial Number (UTN)
Trial acronym
R7128
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Hepatitis C Virus 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Inclusion Criteria Part 3:

* Males or females of non-childbearing potential aged 18 to 65 years. Females must be surgically sterile, or post-menopausal for at least 12 months. Females of child-bearing potential may be enrolled provided they use two methods of acceptable contraception.
* Diagnosed with chronic liver disease consistent with chronic hepatitis C infection, genotype-1, for at least 6 months.
* Genotype 1 Patients who are HCV treatment-naive, with no history of exposure to interferon, ribavirin, or direct antivirals; OR Genoytpe 2 or 3 patients who have previously been treated with interferon.
* Otherwise healthy as determined at screening.
* At least one measurement of serum HCV RNA of = 100,000 IU/mL measured during Screening by the COBAS AmpliPrep/COBAS TaqMan HCV.
* ALT and AST measurement at Screening < 5 times of ULN.
* Liver biopsy obtained within 2 years (24 calendar months) prior to Screening with a fibrosis classification of non-cirrhotic as judged by a local pathologist. Incomplete cirrhosis (Ishak 5) is also considered as cirrhosis. If no history of liver biopsy, a study qualifying biopsy must be performed during the screening period, prior to randomization.
* Negative pregnancy test (for all females) at Screening and Day -1.
* All male patients with female partners of child-bearing potential must use two acceptable methods of contraception (one of which must be a barrier method), during and for 3 months after participation in the study.
* A body mass index (BMI) of = 18 kg/m2, but not exceeding 36.
* Able to abstain from any alcohol (including alcohol-containing products) and able to limit caffeine consumption to two 8-ounce cups of coffee or the equivalent per day, from 72 hours before receiving study drug through the end of the study (Day 56 or early termination).
* Able to effectively communicate with the Investigator and other testing center personnel.
* Able to participate and willing to give written informed consent and comply with the study restrictions.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Positive test at Screening for HAV, HBV, or HIV.
* History or other evidence of a medical condition associated with chronic liver disease, decompensated liver disease, renal disease, immunologically mediated disease, chronic pulmonary disease, cardiac disease, thyroid disease, severe retinopathy, severe psychiatric disease, organ transplantation, cancer, seizure disorder, or pancreatitis.
* Abnormal hematological, biochemical, or coagulation parameters at Screening; or positive fecal occult blood test.
* Estimated creatinine clearance of 90 mL/minute or less at Screening.
* Poorly controlled hypertension, or anyone who at screening or baseline has a BP of 140/90 or greater.
* Type 1 or 2 diabetics with hemoglobin A1C > 7.
* A baseline increased risk for anemia.
* Screening ECG QTc value = 450 ms and/or clinically significant ECG findings.
* Positive results for drugs of abuse at Screening.
* History of clinically significant drug allergy to nucleoside/nucleotide analogues.
* Donation or loss of more than 400 mL blood within 2 months prior to anticipated dose administration.
* Participation in a clinical study with an investigational drug, biologic, or device within 3 months prior to anticipated dose administration.
* Males whose female partner is pregnant.
* Any chronic viral (including HSV), bacterial, mycobacterial, fungal, parasitic, or protozoal infection.
* Serum alpha-feto-protein > 50 ng/mL at screening.
* Receipt of any vaccination within 30 days prior to anticipated dose administration.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2008
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
New Zealand
State/province [7] 0 0
Auckland
Country [8] 0 0
Puerto Rico
State/province [8] 0 0
Santurce

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pharmasset
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Hoffmann-La Roche
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is an adaptive Phase I study to evaluate RO5024048 in the following groups:

* Healthy Volunteers (Part 1 - Single Ascending Dose Study) -Enrollment completed
* Hepatitis C virus (HCV) genotype 1 infected patients who have failed interferon therapy (Part 2- Multiple Ascending Dose Study)-Enrollment Completed
* HCV genotype 1-infected patients who are treatment naive, to be dosed in combination with PEG-IFN and RBV (Part 3 - Combination Dose Study)-Currently Enrolling
* HCV genotype 2-3 infected patients who have previously been treated with interferon but who did not respond, to be dosed in combination with PEG-IFN and RBV (Part 3 - Combination Dose Study)- Currently enrolling

The study aims to determine if RO5024048 is safe and well-tolerated in healthy people and in people infected with hepatitis C virus. The amount of RO5024048 in the blood will be measured during the study and the amount of hepatitis C virus in the blood after each dose will also be measured.

During Part 3 of the study, RO5024048 will be given with PEG-IFN and RBV, two drugs currently used and approved for the treatment of HCV.
Trial website
https://clinicaltrials.gov/study/NCT00382798
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
M. Michelle Berrey, MD
Address 0 0
Pharmasset
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00382798