An Evaluation of Weekly Tafenoquine

NCT02488980 | Completed Phase 2 Results DMC

• 1 other identifier: A-9467
• Study Type: interventional
• Target: 306
• Locations: 0 countries
• Sites: N/A

Brief Summary

This was a placebo controlled, randomised, double-blind, double-dummy study of the efficacy of weekly tafenoquine compared with weekly mefloquine or placebo in the chemosuppression of P. falciparum in Nyanza Province, western Kenya.

Conditions

Falciparum Parasitaemia

Keywords

Falciparum Parasitaemia, Malaria

Outcome Measures

Primary Outcomes (1)

• Prophylactic Outcome Defined by the Subject Having no Positive Smears

  Prophylactic outcome (success/failure) at the end of the prophylactic treatment phase; outcome was based on absence/presence of asexual stage parasites of any Plasmodium species on a single blood smear.

  24 Weeks

Secondary Outcomes (2)

• Protective Efficacy Based on Two Consecutive Positive Smears

  24 Weeks

• Time to a Single Positive Smear

  24 Weeks

Other Outcomes (1)

• Safety (SAEs and AEs)

  28 weeks

Study Arms (3)

Tafenoquine

EXPERIMENTAL

Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.

Drug: Tafenoquine

Mefloquine

ACTIVE COMPARATOR

Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.

Drug: Mefloquine

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Tafenoquine DRUG

Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks.

Tafenoquine

Mefloquine DRUG

Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks.

Mefloquine

Placebo DRUG

Placebo for three days followed by placebo once a week for 24 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female volunteers who provided informed consent (a healthy volunteer was defined as one who was free of ailments that might cause difficulty in evaluating drug efficacy or adverse experiences).
• Subjects aged 18-55 years.
• Subjects planning to reside in the study area for the entire study duration of approximately 70 weeks

You may not qualify if:

• Subjects with positive parasitaemia following halofantrine treatment for radical cure.
• Subjects with any medical condition which, in the opinion of the investigator, made the subject unsuitable to enter the study.
• Subjects with personal or family history of seizures.
• Female subjects with a positive serum beta-HCG5 (tested during screening and within 48 hours of first drug administration and approximately monthly thereafter).
• Women who were pregnant or lactating or who in the opinion of the investigator were at risk of becoming pregnant.
• Subjects with clinically significant abnormalities (to include but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and haematology values. Subjects who had demonstrated hypersensitivity to any of the study drugs especially to any other 8-aminoquinolines.
• Subjects unwilling to report for drug administration or blood drawing during the 70 week duration of the study.
• Subjects with G6PD deficiency.
• Subjects with an abnormal ECG, particularly an extended QTc interval \> 0.42 seconds.
• Subjects taking any other anti-malarial product, or who had taken an antimalarial drug other than halofantrine within the previous two weeks.
• Subjects who had received an investigational drug (a new chemical entity not registered for use) within 30 days or 5 half-lives whichever was the longer.
• Subjects with a history of psychiatric disorder.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• SmithKline Beecham: collaborator

Related Publications (1)

• Novitt-Moreno A, Ransom J, Dow G, Smith B, Read LT, Toovey S. Tafenoquine for malaria prophylaxis in adults: An integrated safety analysis. Travel Med Infect Dis. 2017 May-Jun;17:19-27. doi: 10.1016/j.tmaid.2017.05.008. Epub 2017 May 8.

  PMID: 28495354 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

tafenoquine; Mefloquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Due to high failure rate a DMC was setup to assess if it was appropriate to continue study. DMC concluded that the study should continue in order to meet secondary objectives of evaluating the long-term safety and efficacy.

Results Point of Contact

• Title: Jose Stoute, MD
• Organization: Penn State Hershey Infectious Diseases

noemail@no.com

800-243-1455

Study Officials

• Jose Stoute, MD

  Penn State Hershey Infectious Diseases

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 2, 2015
• Study Start: May 1, 2000
• Primary Completion: October 1, 2000
• Study Completion: March 1, 2003
• Last Updated: May 30, 2017
• Results First Posted: February 24, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share