Acquired Bleeding DisorderPhase 2NCT01601613
Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever
A Phase 2 study testing activated recombinant human factor VII in people with Acquired Bleeding Disorder and Dengue Haemorrhagic Fever, run by Novo Nordisk A/S at 9 sites in 3 countries.
Trial summary
This trial is conducted in Asia. The aim of this is to investigate the efficacy and safety of activated recombinant human factor VII (rFVIIa) in achieving haemostasis in patients with Dengue haemorrhagic fever (DHF). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Acquired Bleeding Disorder, Dengue Haemorrhagic Fever
- What is being tested?
- activated recombinant human factor VII
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Jul 2001to Nov 2002
- Phase
- Phase 2
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with the clinical diagnosis of Dengue Haemorrhagic Fever (DHF)
- Patients with a clinical diagnosis of DHF Grades II and III8, requiring standard replacement therapy
Who cannot join
- Patients with a clinical diagnosis of DHF Grade IV
- Known or suspected allergy to trial product or related products
- Known hypersensitivity to mouse, hamster or bovine protein
- Prior treatment with activated recombinant human factor VII
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Thailand5 sites
Novo Nordisk Investigational Site
Bangkok, 10400
Novo Nordisk Investigational Site
Chiang Mai, 50200
Novo Nordisk Investigational Site
Khon Kaen, 40000
Novo Nordisk Investigational Site
Pisanulok, 65000
Novo Nordisk Investigational Site
Ubonratchathani, 34000
Philippines3 sites
Novo Nordisk Investigational Site
City of Muntinlupa
Novo Nordisk Investigational Site
Manila
Novo Nordisk Investigational Site
Quezon City
About this study
Official title: A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Comparison of Recombinant Factor VIIa (NovoSeven®) and Standard Haemostatic Replacement Therapy in Patients With Dengue Haemorrhagic Fever
This trial is conducted in Asia. The aim of this is to investigate the efficacy and safety of activated recombinant human factor VII (rFVIIa) in achieving haemostasis in patients with Dengue haemorrhagic fever (DHF).
- Being tested
- activated recombinant human factor VII, placebo
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activated recombinant human factor VIIDrug
100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.
placeboDrug
100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.
| Study group | Role | What they receive |
|---|---|---|
| rFVIIa | Experimental | Not described Receives: Drug: activated recombinant human factor VII |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with evidence of bleeding as assessed at 2 hours after first trial product administration
Secondary outcomes (4)
Proportion of subjects requiring standard haemostatic replacement therapy during 2 hours after first trial product administration
Proportion of subjects with effective haemostatic efficacy at 2 hours after first trial product administration
Coagulation related variables
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startJul 2001
- Primary completionNov 2002
- Study completionNov 2002
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 Acquired Bleeding DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601613
- Sponsor's protocol ID
- F7-3015
- Status last verified
- Jan 2017
- First submitted
- 14 May 2012
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Chuansumrit A, Wangruangsatid S, Lektrakul Y, Chua MN, Zeta Capeding MR, Bech OM; Dengue Study Group. Control of bleeding in children with Dengue hemorrhagic fever using recombinant activated factor VII: a randomized, double-blind, placebo-controlled study. Blood Coagul Fibrinolysis. 2005 Nov;16(8):549-55. doi: 10.1097/01.mbc.0000186837.78432.2f.
PubMed 16269927
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Comparison of Recombinant Factor VIIa (NovoSeven®) and Standard Haemostatic Replacement Therapy in Patients With Dengue Haemorrhagic Fever
- ClinicalTrials.gov ID
- NCT01601613
- Acronym / sponsor ID
- F7-3015
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2001
- Primary completion
- Nov 2002 (actual)
- Study completion
- Nov 2002 (actual)
- First posted
- 18 May 2012 (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 trial is conducted in Asia. The aim of this is to investigate the efficacy and safety of activated recombinant human factor VII (rFVIIa) in achieving haemostasis in patients with Dengue haemorrhagic fever (DHF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rFVIIa | Experimental | Drug: activated recombinant human factor VII |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients with the clinical diagnosis of Dengue Haemorrhagic Fever (DHF)
- Patients with a clinical diagnosis of DHF Grades II and III8, requiring standard replacement therapy
Key exclusion criteria (4 listed)
- Patients with a clinical diagnosis of DHF Grade IV
- Known or suspected allergy to trial product or related products
- Known hypersensitivity to mouse, hamster or bovine protein
- Prior treatment with activated recombinant human factor VII
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 |
|---|---|---|
| activated recombinant human factor VII100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion. | Drug | rFVIIa |
| placebo100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion. | Drug | placebo |
Primary outcome
Proportion of subjects with evidence of bleeding as assessed at 2 hours after first trial product administration
4 secondary outcomes
Proportion of subjects requiring standard haemostatic replacement therapy during 2 hours after first trial product administration
Proportion of subjects with effective haemostatic efficacy at 2 hours after first trial product administration
Coagulation related variables
Adverse events
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 11 Jan 2017.
- Results publication: PubMed 16269927Chuansumrit A, Wangruangsatid S, Lektrakul Y, Chua MN, Zeta Capeding MR, Bech OM; Dengue Study Group. Control of bleeding in children with Dengue hemorrhagic fever using recombinant activated factor VII: a randomized, double-blind, placebo-controlled study. Blood Coagul Fibrinolysis. 2005 Nov;16(8):549-55. doi: 10.1097/01.mbc.0000186837.78432.2f.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing activated recombinant human factor VII in people with Acquired Bleeding Disorder and Dengue Haemorrhagic Fever, run by Novo Nordisk A/S at 9 sites in 3 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 2 inclusion and 4 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 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Thailand, Philippines, Malaysia. 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 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?
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?
Proportion of subjects with evidence of bleeding as assessed at 2 hours after first trial product administration. 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 NCT01601613, 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 11 Jan 2017.