Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01376167 | Ph 2B/3 Tafenoquine (TFQ) Study in Prevention of Vivax Relapse | PHASE2 | COMPLETED | 851 | — | — | Apr 24, 2014 | Nov 18, 2016 | Apr 23, 2018 | 14 | Bangladesh, Brazil +6 |
A participant was considered to have demonstrated recurrence-free efficacy at 6 months if: a) Participant had non-zero P vivax asexual parasite count at Baseline. b) Participant showed initial clearance of P vivax parasitemia defined as two negative asexual P vivax parasite counts, with at least 6 hours between the counts, and no positive counts in the interval. c) Participant had no positive asexual P vivax parasite count at any assessment prior to or on Study Day 201 following initial parasite clearance. d) Participant did not take a concomitant medication with anti-malarial activity at any point between Study Day 1 and their last parasite assessment. e) Participant is parasite-free at 6 months. Participants were censored if they did not have P.vivax at Baseline, or took a drug with anti-malarial action despite not having malaria parasites, or did not have a 6 month assessment. The number of participants with recurrence-free efficacy at 6 months has been summarized.
| Arm | Type | Description |
|---|---|---|
| Tafenoquine 50mg | EXPERIMENTAL | On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered. 50mg Tafenoquine will be administered on either Day 1 or Day2 depending on when eligibility is confirmed. |
| Tafenoquine 100mg | EXPERIMENTAL | On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered. 100mg Tafenoquine will be administered on either Day 1 or Day2 depending on when eligibility is confirmed. |
| Tafenoquine 300mg | EXPERIMENTAL | On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered. 300mg Tafenoquine will be administered on either Day 1 or Day2 depending on when eligibility is confirmed. |
| Tafenoquine 600mg | EXPERIMENTAL | On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered. 600mg Tafenoquine will be administered on either Day 1 or Day2 depending on when eligibility is confirmed. |
| Primaquine 15mg | ACTIVE_COMPARATOR | On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered. 15mg Primaquine once daily Days 2-15. |
| Chloroquine only | PLACEBO_COMPARATOR | On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered. |
| Tafenoquine 300mg (Part 2) | EXPERIMENTAL | On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered. 300mg Tafenoquine will be administered on either Day 1 or Day2 depending on when eligibility is confirmed. |
| Primaquine 15mg (Part 2) | ACTIVE_COMPARATOR | On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered. 15mg Primaquine once daily Days 2-15 |
| Chloroquine only (Part 2) | PLACEBO_COMPARATOR | On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered |
| Name | Type | Description |
|---|---|---|
| Chloroquine 600mg | DRUG | 600mg Chloroquine given to each subject on Day 1 and Day2 of the trial |
| Chloroquine 300mg | DRUG | 300mg Chloroquine given to each subject on Day 3 of the trial |
| Tafenoquine 50mg | DRUG | single dose 50mg Tafenoquine given to subject on treatment arm 1 on Days 1 or 2 |
| Tafenoquine 100mg | DRUG | single dose 100mg Tafenoquine given to subject on treatment arm 2 on Days 1 or 2 |
| Tafenoquine 300mg | DRUG | single dose 300mg Tafenoquine given to subject on treatment arm 3 on Days 1 or 2 |
| Tafenoquine 600mg | DRUG | single dose 600mg Tafenoquine given to subject on treatment arm 4 on Days 1 or 2 |
| Primaquine 15mg | DRUG | 15mg Primaquine given once daily to subject on treatment arm 5 on Days 2 to 15. |
| Chloroquine 600mg (Part 2 ) | DRUG | 600mg Chloroquine given to each subject on Day 1 and Day2 of the trial. |
| Chloroquine 300mg (Part 2 ) | DRUG | 300mg Chloroquine given to each subject on Day 3 of the trial. |
| Tafenoquine 300mg (Part 2) | DRUG | single dose 300mg Tafenoquine given to subject on treatment arm 3 on Days 1 or 2. |
| Primaquine 15mg (Part2 ) | DRUG | 15mg Primaquine given once daily to subject on treatment arm 3 on Days 2 to 15. |
Inclusion Criteria: - Positive Giemsa smear for P. vivax * Parasite density \>100 and \<200,000/μL * ≥16 years * A female is eligible if she is non-pregnant, nonlactating and if she is of: - non-child bearing potential defined as: post-menopausal (12 months of spontaneous amenorrhea or 6 months of ...