DenguePhase 1NCT01096576
A Study of Balapiravir in Patients With Dengue Virus Infection
A Phase 1 study testing balapiravir [RO4588161] in people with Dengue, run by Hoffmann-La Roche at 1 site in Vietnam.
Trial summary
This randomized, double-blind, multiple-dose, placebo-controlled study will evaluate the safety, tolerability and efficacy of balapiravir in adult male patients with confirmed dengue virus infection whose symptoms began within the 48 hours preceding the first administration of balapiravir. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Dengue
- What is being tested?
- balapiravir [RO4588161]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteVietnam
- Study dates
- Jul 2010to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male patients, 18-65 years of age
- dengue virus infection (confirmed by NS1 strip test) with symptom onset </=48 hours before first study drug administration
- patients and their partners of childbearing potential must use 2 forms of contraception until 3 months after receiving the last dose of study drug
- BMI between 18 and 35
Who cannot join
- positive test at screening for HIV using point of care test, or known HIV infection
- history of any disease known to cause significant alteration in immunologic function or autoimmune disease
- patients taking steroid or other immuno-suppressive therapies
- positive test for drugs of abuse or alcohol using point of care test
- clinically significant abnormal laboratory test results which are deemed unassociated with dengue infection or, alternatively, are diagnostic of dengue shock syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Dengue Virus Polymerase Inhibitor (Balapiravir) in Male Patients With Confirmed Dengue Virus Infection
This randomized, double-blind, multiple-dose, placebo-controlled study will evaluate the safety, tolerability and efficacy of balapiravir in adult male patients with confirmed dengue virus infection whose symptoms began within the 48 hours preceding the first administration of balapiravir. Patients will be randomized to receive either balapiravir or placebo, orally twice daily for 5 days. Anticipated time on treatment as in-patient is 7 days, with an out-patient follow-up to week 12. Target sample size is <200
- Conditions
- Dengue
- Being tested
- balapiravir [RO4588161], placebo
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balapiravir [RO4588161]Drug
sequential cohorts receiving doses orally twice daily for 5 days
placeboDrug
orally twice daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: balapiravir [RO4588161] |
| B | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: Adverse events, laboratory parameters, vital signs
Measured: days 1-7 and on follow-up days 14, 28 and 84
Secondary outcomes (6)
Viral load
Measured: days 1-7 and 14
Pharmacokinetics: plasma concentrations of RO1042897, balapiravir and metabolites
Measured: multiple sampling days 1 and 5
Body temperature
Measured: days 1-7 and on follow-up days 14, 28 and 84
Immunological parameters: plasma samples (cytokines)
Measured: days 1-7 and 14
Hematological parameters: blood samples (red and white blood cell count, hemoglobin, hematocrit, reticulocyte count, fibrinogen, platelet count)
Measured: days 1-7, and on follow-up days 14, 28 and 84
Quality of life
Measured: assessments days 1, 3, 5, 7, 14, 28 and 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DengueStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 1
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096576
- Sponsor's protocol ID
- PP22799
- Status last verified
- Nov 2016
- First submitted
- 17 Mar 2010
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Nguyen NM, Tran CN, Phung LK, Duong KT, Huynh Hle A, Farrar J, Nguyen QT, Tran HT, Nguyen CV, Merson L, Hoang LT, Hibberd ML, Aw PP, Wilm A, Nagarajan N, Nguyen DT, Pham MP, Nguyen TT, Javanbakht H, Klumpp K, Hammond J, Petric R, Wolbers M, Nguyen CT, Simmons CP. A randomized, double-blind placebo controlled trial of balapiravir, a polymerase inhibitor, in adult dengue patients. J Infect Dis. 2013 May 1;207(9):1442-50. doi: 10.1093/infdis/jis470. Epub 2012 Jul 17.
PubMed 22807519
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Dengue Virus Polymerase Inhibitor (Balapiravir) in Male Patients With Confirmed Dengue Virus Infection
- ClinicalTrials.gov ID
- NCT01096576
- Acronym / sponsor ID
- PP22799
- Conditions
- Dengue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, multiple-dose, placebo-controlled study will evaluate the safety, tolerability and efficacy of balapiravir in adult male patients with confirmed dengue virus infection whose symptoms began within the 48 hours preceding the first administration of balapiravir. Patients will be randomized to receive either balapiravir or placebo, orally twice daily for 5 days. Anticipated time on treatment as in-patient is 7 days, with an out-patient follow-up to week 12. Target sample size is <200
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: balapiravir [RO4588161] |
| B | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male patients, 18-65 years of age
- dengue virus infection (confirmed by NS1 strip test) with symptom onset </=48 hours before first study drug administration
- patients and their partners of childbearing potential must use 2 forms of contraception until 3 months after receiving the last dose of study drug
- BMI between 18 and 35
Key exclusion criteria (5 listed)
- positive test at screening for HIV using point of care test, or known HIV infection
- history of any disease known to cause significant alteration in immunologic function or autoimmune disease
- patients taking steroid or other immuno-suppressive therapies
- positive test for drugs of abuse or alcohol using point of care test
- clinically significant abnormal laboratory test results which are deemed unassociated with dengue infection or, alternatively, are diagnostic of dengue shock syndrome
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 |
|---|---|---|
| balapiravir [RO4588161]sequential cohorts receiving doses orally twice daily for 5 days | Drug | A |
| placeboorally twice daily for 5 days | Drug | B |
Primary outcome
Safety and tolerability: Adverse events, laboratory parameters, vital signs
Time frame: days 1-7 and on follow-up days 14, 28 and 84
6 secondary outcomes
Viral load
Time frame: days 1-7 and 14
Pharmacokinetics: plasma concentrations of RO1042897, balapiravir and metabolites
Time frame: multiple sampling days 1 and 5
Body temperature
Time frame: days 1-7 and on follow-up days 14, 28 and 84
Immunological parameters: plasma samples (cytokines)
Time frame: days 1-7 and 14
Hematological parameters: blood samples (red and white blood cell count, hemoglobin, hematocrit, reticulocyte count, fibrinogen, platelet count)
Time frame: days 1-7, and on follow-up days 14, 28 and 84
Quality of life
Time frame: assessments days 1, 3, 5, 7, 14, 28 and 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 22807519Nguyen NM, Tran CN, Phung LK, Duong KT, Huynh Hle A, Farrar J, Nguyen QT, Tran HT, Nguyen CV, Merson L, Hoang LT, Hibberd ML, Aw PP, Wilm A, Nagarajan N, Nguyen DT, Pham MP, Nguyen TT, Javanbakht H, Klumpp K, Hammond J, Petric R, Wolbers M, Nguyen CT, Simmons CP. A randomized, double-blind placebo controlled trial of balapiravir, a polymerase inhibitor, in adult dengue patients. J Infect Dis. 2013 May 1;207(9):1442-50. doi: 10.1093/infdis/jis470. Epub 2012 Jul 17.
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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.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing balapiravir [RO4588161] in people with Dengue, run by Hoffmann-La Roche at 1 site in Vietnam.
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 4 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability: Adverse events, laboratory parameters, vital signs (time frame: days 1-7 and on follow-up days 14, 28 and 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01096576, which also lists 1 linked publication.
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 2 Nov 2016.