Acquired Bleeding DisorderPhase 2NCT01562821
Safety and Efficacy of Activated Recombinant Human Factor VII in Cirrhotic Patients Undergoing Partial Hepatectomy
A Phase 2 study testing activated recombinant human factor VII in people with Acquired Bleeding Disorder and Cirrhosis, run by Novo Nordisk A/S at 7 sites in 3 countries.
Trial summary
This trial is conducted in Asia. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in cirrhotic patients scheduled to undergo partial hepatectomy due to liver cancer or benign tumours. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Acquired Bleeding Disorder, Cirrhosis
- What is being tested?
- activated recombinant human factor VII
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 235 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Jul 2001to Dec 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis (Child-Turcotte Score A, B, or C)
- Scheduled to undergo partial hepatectomy due to liver cancer or benign tumours
Who cannot join
- Portal vein thrombosis
- Clinically documented DVT (deep venous thrombosis)
- Clinically documented symptoms of severe cardiovascular disease and/or previous myocardial/pulmonary infarction or stroke
- Present renal insufficiency requiring dialysis
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
China3 sites
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100021
Novo Nordisk Investigational Site
Beijing
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200438
Taiwan2 sites
Novo Nordisk Investigational Site
Taipei, 100
Novo Nordisk Investigational Site
Taipei, 112
Thailand2 sites
Novo Nordisk Investigational Site
Bangkok, 10330
Novo Nordisk Investigational Site
Bangkok, 10700
About this study
Official title: A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Cirrhotic Patients Scheduled to Undergo Partial Hepatectomy Due to Liver Cancer or Benign Tumours
This trial is conducted in Asia. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in cirrhotic patients scheduled to undergo partial hepatectomy due to liver cancer or benign tumours.
- Conditions
- Acquired Bleeding Disorder, Cirrhosis
- Being tested
- activated recombinant human factor VII, placebo
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activated recombinant human factor VIIDrug
An initial bolus dose of 50 mcg/kg body weight (BW) followed by 50 mcg/kg BW every second hour until completion of surgery
activated recombinant human factor VIIDrug
An initial bolus dose of 100 mcg/kg body weight (BW) followed by 100 mcg/kg BW every second hour until completion of surgery
placeboDrug
An initial placebo bolus dose followed by placebo every second hour until completion of surgery
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Not described Receives: Drug: activated recombinant human factor VII |
| High dose | 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.
The RBC transfusion requirements
Secondary outcomes (3)
Number of transfusion product units
Change in coagulation-related parameters
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startJul 2001
- Primary completionDec 2002
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 235 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
- NCT01562821
- Sponsor's protocol ID
- F7LIVER-1313
- Status last verified
- Jan 2017
- First submitted
- 22 Mar 2012
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Shao YF, Yang JM, Chau GY, Sirivatanauksorn Y, Zhong SX, Erhardtsen E, Nivatvongs S, Lee PH. Safety and hemostatic effect of recombinant activated factor VII in cirrhotic patients undergoing partial hepatectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Am J Surg. 2006 Feb;191(2):245-9. doi: 10.1016/j.amjsurg.2005.10.019.
PubMed 16442954Levy JH, Fingerhut A, Brott T, Langbakke IH, Erhardtsen E, Porte RJ. Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile. Transfusion. 2006 Jun;46(6):919-33. doi: 10.1111/j.1537-2995.2006.00824.x.
PubMed 16734808
Study at a glance
From the registry record, last updated by the sponsor on 13 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 Trial Evaluating the Safety and Efficacy of A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Cirrhotic Patients Scheduled to Undergo Partial Hepatectomy Due to Liver Cancer or Benign Tumours
- ClinicalTrials.gov ID
- NCT01562821
- Acronym / sponsor ID
- F7LIVER-1313
- Conditions
- Acquired Bleeding Disorder, Cirrhosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2001
- Primary completion
- Dec 2002 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 26 Mar 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 trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in cirrhotic patients scheduled to undergo partial hepatectomy due to liver cancer or benign tumours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: activated recombinant human factor VII |
| High dose | Experimental | Drug: activated recombinant human factor VII |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cirrhosis (Child-Turcotte Score A, B, or C)
- Scheduled to undergo partial hepatectomy due to liver cancer or benign tumours
Key exclusion criteria (4 listed)
- Portal vein thrombosis
- Clinically documented DVT (deep venous thrombosis)
- Clinically documented symptoms of severe cardiovascular disease and/or previous myocardial/pulmonary infarction or stroke
- Present renal insufficiency requiring dialysis
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 VIIAn initial bolus dose of 50 mcg/kg body weight (BW) followed by 50 mcg/kg BW every second hour until completion of surgery | Drug | Low dose |
| activated recombinant human factor VIIAn initial bolus dose of 100 mcg/kg body weight (BW) followed by 100 mcg/kg BW every second hour until completion of surgery | Drug | High dose |
| placeboAn initial placebo bolus dose followed by placebo every second hour until completion of surgery | Drug | Placebo |
Primary outcome
The RBC transfusion requirements
3 secondary outcomes
Number of transfusion product units
Change in coagulation-related parameters
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 13 Jan 2017.
- Results publication: PubMed 16442954Shao YF, Yang JM, Chau GY, Sirivatanauksorn Y, Zhong SX, Erhardtsen E, Nivatvongs S, Lee PH. Safety and hemostatic effect of recombinant activated factor VII in cirrhotic patients undergoing partial hepatectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Am J Surg. 2006 Feb;191(2):245-9. doi: 10.1016/j.amjsurg.2005.10.019.
- Results publication: PubMed 16734808Levy JH, Fingerhut A, Brott T, Langbakke IH, Erhardtsen E, Porte RJ. Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile. Transfusion. 2006 Jun;46(6):919-33. doi: 10.1111/j.1537-2995.2006.00824.x.
- 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
7 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 Cirrhosis, run by Novo Nordisk A/S at 7 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 13 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 7 sites in China, Taiwan, Thailand. 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?
The RBC transfusion requirements. 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 NCT01562821, which also lists 2 linked publications.
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 13 Jan 2017.