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Trial registered on ANZCTR


Registration number
ACTRN12615000390583
Ethics application status
Approved
Date submitted
10/04/2015
Date registered
28/04/2015
Date last updated
13/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
SPARTA Doublet: A Phase 2, Randomized, Double-Blind (Subject- and Investigator-Blind, Sponsor-Open), Placebo-Controlled Trial to Investigate the Safety, Tolerability, and Efficacy of ACH-0143422 in Combination with
ACH-0143102 for 12, 8, or 6 Weeks in Treatment-Naive Subjects with Chronic Hepatitis C
Scientific title
SPARTA Doublet: A Phase 2, Randomized, Double-Blind (Subject- and Investigator-Blind, Sponsor-Open), Placebo-Controlled Trial to Investigate the Safety, Tolerability, and Efficacy of ACH-0143422 in Combination with
ACH-0143102 for 12, 8, or 6 Weeks in Treatment-Naive Subjects with Chronic Hepatitis C
Secondary ID [1] 286433 0
None
Universal Trial Number (UTN)
U1111-1168-0662
Trial acronym
SPARTA Doublet
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 294602 0
Condition category
Condition code
Infection 294903 294903 0 0
Other infectious diseases
Oral and Gastrointestinal 295065 295065 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
Active treatment is 700 mg of ACH­-0143422 (oral capsule) with 50 mg of ACH-­0143102 (oral tablet) once daily (QD) or placebo taken for the following durations.

Cohort 1
Group 1 – ACH­-0143422 for 3 days, then 12 weeks of active treatment
Group 2 – ACH­-0143422 placebo for 3 days, then 12 weeks active treatment
Group 3 – ACH-­0143422 placebo for 3 days, then 12 weeks placebo for each drug

Cohort 2
Group 4 – 8 weeks of active treatment
Group 5 – 8 weeks placebo for each drug

Cohort 3
Group 6 – 6 weeks of active treatment
Group 7 – 6 weeks placebo for each drug

All groups will be dosed under fed conditions. Adherence to required dosing will be monitored by counting number of returned tablets/capsules.
Intervention code [1] 291511 0
Treatment: Drugs
Comparator / control treatment
Placebo (Microcrystalline cellulose capsule or tablet). The placebo for ACH-0143422 will be a capsule and the placebo for ACH-0143102 will be a tablet so the participant does not know if they are taking placebo or active medication.
Control group
Placebo

Outcomes
Primary outcome [1] 294660 0
To assess the safety of ACH-0143422 and ACH-0143102 as determined by the incidence of serious adverse events (SAEs), Grade 3 or 4 adverse events (AEs) and laboratory abnormalities, and discontinuations due to AEs.
Timepoint [1] 294660 0
30 days after treatment stops
Primary outcome [2] 294661 0
To determine the proportion of subjects with SVR12, defined as sustained virologic response [hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ)] 12 weeks after the end of active treatment), in subjects who receive 12, 8, or 6 weeks of active treatment with ACH-0143422 and ACH-0143102. This result is obtained by a test on the participant's blood sample.
Timepoint [2] 294661 0
12 weeks after treatment stops
Secondary outcome [1] 313821 0
To determine the proportion of subjects with SVR4 and SVR24, defined as HCV RNA < LLOQ, 4 and 24 weeks after the end of active treatment, in subjects who received ACH-0143422 and ACH-0143102 for 12, 8, or 6 weeks. This result is obtained by a test on the participant's blood sample.
Timepoint [1] 313821 0
24 weeks after treatment stops
Secondary outcome [2] 313822 0
To determine the pharmacokinetics (PK) of ACH-0143422 (and its inactive metabolite ACH-0143420) and ACH-0143102 when co-administered in patients with chronic hepatitis C (CHC) infection. This result is obtained by a serum assay on the participant's blood sample.
Timepoint [2] 313822 0
Final time point is 24 weeks after treatment stops. Intensive PK time points are pre-dose, and 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours after dosing. Trough PK samples will be obtained at Weeks 1, 3-12, 14, 16, 20, 24 and 36.

Eligibility
Key inclusion criteria
Key inclusion criteria are:
1. Males and females aged 18 years and less than 70 years.
2. Chronic Hepatitis C infection
3. Genotype 1 infection
4. HCV RNA more than or equal to 10,000 IU/mL at screening
5. No clinically relevant health abnormalities
6. Agree to use effective contraception (defined in the protocol)
7. Participants must be HCV treatment naïve
8. Participants must have absence of cirrhosis
Minimum age
18 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key exclusion criteria are:
1. BMI of more than 36.0 kg/m2.
2. Pregnant or nursing females
3. Participation in any clinical trial within 30 days prior to study drug administration.
4. Previous treatment (defined in the protocol)
5. Previous use of certain medication (defined in protocol)
6. Have clinically significant laboratory abnormalities or illnesses (defined in protocol), including liver damage or heart conditions

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)
Central randomization via a computer-generated paper list or Interactive Web Response System (IWRS)
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 administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Safety data from individual treatment duration (12, 8, or 6 weeks) will be presented separately.

The following safety endpoints will be summarized within each treatment duration cohort, active versus placebo, for subjects receiving at least one dose of study therapy;
- SAEs;
- AEs leading to discontinuation of study therapy;
- AEs (related and regardless of relationship to study therapy);
- Laboratory abnormalities by toxicity grade.

Due to the exploratory nature of this study, no power or sample size calculations were performed. The number of subjects was chosen on an empirical basis.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
22/06/2015
Actual
Date of last participant enrolment
Anticipated
28/08/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 6779 0
New Zealand
State/province [1] 6779 0

Funding & Sponsors
Funding source category [1] 291003 0
Commercial sector/Industry
Name [1] 291003 0
Achillion Pharmaceuticals, Inc
Country [1] 291003 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Achillion Pharmaceuticals, Inc
Address
300 George Street
New Haven, CT 06511
Country
United States of America
Secondary sponsor category [1] 289681 0
Commercial sector/Industry
Name [1] 289681 0
Clinical Network Services
Address [1] 289681 0
PO Box 78312, Grey Lynn, Auckland 1245
Country [1] 289681 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292588 0
Northern A Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 292588 0
Ethics committee country [1] 292588 0
New Zealand
Date submitted for ethics approval [1] 292588 0
26/03/2015
Approval date [1] 292588 0
20/04/2015
Ethics approval number [1] 292588 0
tbc

Summary
Brief summary
The purpose of the study is to examine the safety, efficacy, and tolerability of ACH-0143422 when used in combination with ACH-0143102. The effect of treatment duration, 12 weeks, 8 weeks, and 6 weeks, will also be examined. Within each treatment duration cohort (i.e. 12, 8, or 6 weeks), subjects will be randomized to receive either an active or placebo regimen.
Cohort 1 will have 24 patients, Cohort 2 and Cohort 3 will have 18 patients.

The 12-week groups will be closely monitored during drug treatment for safety or PK issues which might indicate an unacceptable risk to treated subjects, and continuation of dosing will depend on the outcome of early safety and PK assessments. An analysis of safety and PK data will be performed after all subjects in the 12-week cohort have completed 4 weeks of combination treatment, and dosing will continue in the 12-week cohorts assuming that no safety or PK issues are identified that would preclude continued dosing. Intensive PK sampling will be performed during the first 2 weeks of treatment in these groups to evaluate the PK of ACH-0143422 and ACH-0143102 when dosed in combination. In order to preserve the blind of this study, safety and PK sampling assessments will also be required for subjects receiving placebo.

In the absence of drug exposures that exceed threshold levels in the 12-week cohort, no intensive PK will be performed on subjects in the 8- and 6-week cohorts.

After a 4-week review of safety and PK from the 12-week cohort, enrolment into the 8-week cohort will be initiated if safety and PK findings in the 12-week cohort are considered acceptable for continued dosing.

Enrolment into the 6-week cohort will be initiated after subjects in the 12-week cohort have completed 6 weeks of treatment if safety and PK findings in the 12-week cohort are considered acceptable for continued dosing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56118 0
Prof Edward Gane
Address 56118 0
Auckland Clinical Studies Ltd PO Box 8963 Symonds Street Auckland 1150
Country 56118 0
New Zealand
Phone 56118 0
+64 9 373 3474
Fax 56118 0
Email 56118 0
[email protected]
Contact person for public queries
Name 56119 0
John Lahey
Address 56119 0
Achillion Pharmaceuticals Inc, 300, George Street, New Haven CT 06511
Country 56119 0
United States of America
Phone 56119 0
+1 203-752-5437
Fax 56119 0
Email 56119 0
[email protected]
Contact person for scientific queries
Name 56120 0
John Lahey
Address 56120 0
Achillion Pharmaceuticals Inc, 300, George Street, New Haven CT 06511
Country 56120 0
United States of America
Phone 56120 0
+1 203-752-5437
Fax 56120 0
Email 56120 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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