Cure RatePhase 2NCT01860989
A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection
A Phase 2 study testing KAE609 in people with Cure Rate, run by Novartis Pharmaceuticals at 4 sites in 2 countries.
Trial summary
This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/day Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Cure Rate
- What is being tested?
- KAE609
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jul 2013to Aug 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients aged 20 to 60 years
- Presence of mono-infection of P. falciparum
- Weight between 40 kg to 90 kg
Who cannot join
- Patients with signs and symptoms of severe/complicated malaria
- Mixed Plasmodium infection
- Presence of other serious or chronic clinical condition requiring hospitalization.
- Severe malnutrition
- Significant chronic medical conditions which in the opinion of the investigator preclude enrollment into the study
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Thailand3 sites
Novartis Investigative Site
Ratchabari, 70180
Novartis Investigative Site
Si Sa Ket, 33140
Novartis Investigative Site
Tak, 63140
About this study
Official title: An Open Label, Single Dose Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum Malaria Mono-infection
This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/day
Read the detailed description
the study is comprised of 4 sequential cohorts, in total there will be up to 48 patients enrolled in the study.
cohort 1: 6-12 patients receive 75mg single dose. cohort 2: 6-12 patients receive 150mg single dose. cohort 3: 6-12 patients receive 225mg single dose. cohort 4: 6-12 patients receive 300mg single dose. After approximately every 6 patients in any cohort have been treated with a given dose and complete the first 15 days, a safety and tolerability data review will be conducted by a Data Monitoring Committee(DMC). Consensus agreement of DMC is required to either escalate to the next dose level or expand a given cohort with an additional 6 patients in order to obtain more safety data.
- Conditions
- Cure Rate
- Being tested
- KAE609
- Keywords
- parasitemia
- Medical subject headings
- Parasitemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAE609Drug
KAE609 75mg single dose
KAE609Drug
KAE609 150mg single dose
KAE609Drug
KAE609 225mg single dose
KAE609Drug
KAE609 300mg single dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose Receives: Drug: KAE609 |
| Cohort 2 | Experimental | 6-12 subjects with Plasmodium falciparum malaria will receive 150 mg KAE609 as a single dose Receives: Drug: KAE609 |
| Cohort 3 | Experimental | 6 to 12 subjects with Plasmodium falciparum malaria will receive 225 mg KAE609 as a single dose Receives: Drug: KAE609 |
| Cohort4 | Experimental | 6- 12 subjects with Plasmodium falciparum malaria will receive 300 mg KAE609 as a single dose Receives: Drug: KAE609 |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day Cure Rate
28-day cure rate was measured by the endpoint of complete cure without recrudescence before Day 29. The primary variable of 28-day cure rate was defined as the proportion of patients with clearance of asexual parasitemia (by blood film) by day 6 of the study, and without subsequent recrudescence (by blood film).
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cure RateStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860989
- Sponsor's protocol ID
- CKAE609X2202
- Status last verified
- Sep 2015
- First submitted
- 21 May 2013
- Last updated
- 10 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Dose Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum Malaria Mono-infection
- ClinicalTrials.gov ID
- NCT01860989
- Acronym / sponsor ID
- CKAE609X2202
- Conditions
- Cure Rate
- Keywords
- parasitemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 23 May 2013 (estimated)
- Results
- Posted 3 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/day
Detailed description
the study is comprised of 4 sequential cohorts, in total there will be up to 48 patients enrolled in the study.
cohort 1: 6-12 patients receive 75mg single dose. cohort 2: 6-12 patients receive 150mg single dose. cohort 3: 6-12 patients receive 225mg single dose. cohort 4: 6-12 patients receive 300mg single dose. After approximately every 6 patients in any cohort have been treated with a given dose and complete the first 15 days, a safety and tolerability data review will be conducted by a Data Monitoring Committee(DMC). Consensus agreement of DMC is required to either escalate to the next dose level or expand a given cohort with an additional 6 patients in order to obtain more safety data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: KAE6096-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose |
| Cohort 2 | Experimental | Drug: KAE6096-12 subjects with Plasmodium falciparum malaria will receive 150 mg KAE609 as a single dose |
| Cohort 3 | Experimental | Drug: KAE6096 to 12 subjects with Plasmodium falciparum malaria will receive 225 mg KAE609 as a single dose |
| Cohort4 | Experimental | Drug: KAE6096- 12 subjects with Plasmodium falciparum malaria will receive 300 mg KAE609 as a single dose |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female patients aged 20 to 60 years
- Presence of mono-infection of P. falciparum
- Weight between 40 kg to 90 kg
Key exclusion criteria (5 listed)
- Patients with signs and symptoms of severe/complicated malaria
- Mixed Plasmodium infection
- Presence of other serious or chronic clinical condition requiring hospitalization.
- Severe malnutrition
- Significant chronic medical conditions which in the opinion of the investigator preclude enrollment into the study
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 |
|---|---|---|
| KAE609KAE609 75mg single dose | Drug | Cohort 1 |
| KAE609KAE609 150mg single dose | Drug | Cohort 2 |
| KAE609KAE609 225mg single dose | Drug | Cohort 3 |
| KAE609KAE609 300mg single dose | Drug | Cohort4 |
Primary outcome
28-day Cure Rate
Time frame: Day 28
28-day cure rate was measured by the endpoint of complete cure without recrudescence before Day 29. The primary variable of 28-day cure rate was defined as the proportion of patients with clearance of asexual parasitemia (by blood film) by day 6 of the study, and without subsequent recrudescence (by blood film).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cure Rate
Not yet recruitingPhase 4
Comparison of Itraconazole With Itraconazole and Isotretinoin in the Treatment Duration, Safety a n d Cure Rate in Adult Patients of Tinea Corporis/ Cruris-A Randomised Controlled Trail
Tinea Corporis
Active, not recruitingPhase 3
Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer
Breast Cancer
RecruitingObservational study
Efficacy of Thermal Ablation Combined With Antithyroid Drugs in the Treatment of Primary Hyperthyroidism
Complication Rate, Efficacy and Safety
RecruitingPhase 4
CURE-H. Pylori: A Trial on the Combination of Anti-Ulcerants and Levofloxacin-Based Therapy for Helicobacter Pylori Eradication
H. Pylori Gastrointestinal Disease, H.Pylori Infection
Not yet recruitingPhase 4
Prospective Cohort Study on PEG-IFN-α-2b in Improving Clinical Cure Rate of Pediatric Patients With Chronic Hepatitis B
HBV, Chronic Hepatitis B Virus
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KAE609 in people with Cure Rate, run by Novartis Pharmaceuticals at 4 sites in 2 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 3 inclusion and 5 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 10 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Thailand, Vietnam. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
28-day Cure Rate (time frame: Day 28). 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 10 Sep 2015.