r-Hirudin (Thrombexx) Efficacy in Treatment of HaematomasPhase 4NCT01960569
Topical r-Hirudin ( Thrombexx ) Efficacy in Treatment of Haematomas
A Phase 4 study testing active product ( Thrombexx) assigned to arm 1 in people with r-Hirudin (Thrombexx) Efficacy in Treatment of Haematomas, run by MinaPharm Pharmaceuticals at 1 site in Egypt.
Trial summary
Single centre ,Phase IV , interventional, The study includes : 200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo . The patients will be randomized to the active product (arm 1) or to placebo (arm 2). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- r-Hirudin (Thrombexx) Efficacy in Treatment of Haematomas
- What is being tested?
- active product ( Thrombexx) assigned to arm 1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2013to Apr 2014
- Phase
- Phase 4
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age of patients between 20 and 60 years old.
- Patients with all types of haematoma.
Who cannot join
- Presence of infected wound requiring hospitalization or surgical intervention.
- History of allergy or hypersensitivity to any of the ingredients.
- Patients with coagulation disorders like haemophilia.
- Patients who are on anticoagulants like Warfarin and Acetylsalicylic acid .
- Patients who are taking digestive enzymes like alfa chemotrypsin.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Prof. Mahmoud Hafez
Cairo, Cairo Governorate
Ahmed Moneer, Dr, 002 0100 8608676, dr_ahmedmoneer@yahoo.com
Mahmoud Hafez, Professor
About this study
Official title: Single Centre,Randomized,Phase IV Study to Assess the Topical r-Hirudin (Thrombexx)Efficacy in the Patients With Haematomas
Single centre ,Phase IV , interventional, The study includes :
200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo .
The patients will be randomized to the active product (arm 1) or to placebo (arm 2).
The study consists of 4 visits as the following :
- Visit 1 : on day 1 to check patient eligibility and also for randomization .
- Visit 2 : on day 4 to assess target parameters
- Visit 3 : on day 8 to assess target parameters
- Visit 4 : on day 16 to assess target parameters
Read the detailed description
Single centre ,Phase IV , interventional, The study includes :
- 200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo .
The patients will be randomized to the active product (arm 1) or to placebo (arm 2).
The study consists of 4 visits as the following :
- Visit 1 : on day 1 to check patient eligibility and also for randomization .
- Visit 2 : on day 4 to assess target parameters
- Visit 3 : on day 8 to assess target parameters
- Visit 4 : on day 16 to assess target parameters
- Study objective :Assessment the Efficacy of Topical r-Hirudin in treatment of haematomas ,also in resolving of the associated oedema
- Study duration : 6 months
- Selection of trial subjects:
Inclusion Criteria :
- Age of patients between 20 and 60 years old.
- Patients with all types of haematomas.
Exclusion Criteria:
- Presence of infected wound requiring hospitalization or surgical intervention.
- History of allergy or hypersensitivity to any of the ingredients.
- Patients with coagulation disorders like haemophilia.
- Patients who are on anticoagulants like Warfarin and Acetylsalicylic acid .
- Patients who are taking digestive enzymes like alfa chemotrypsin.
- Target parameters :
1.Size of haematoma.( Measured by ruler) , The ruler will measure the longest 2 intersecting line.
2.Size of oedema : by measurement of oedema circumference
3.Pain (by Vas score).
4.Change in colour ( by colour grade scale ) .
- Being tested
- active product ( Thrombexx) assigned to arm 1, Placebo assigned to arm 2
- Keywords
- Thrombexx, Topical r-Hirudin, Efficacy, haematoma
- Medical subject headings
- Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active product ( Thrombexx) assigned to arm 1Drug
Also called Topical r-Hirudin
Dispense 2-3 cm of cream or gel, 2-3 times per day and carry out a light massage until complete
Placebo assigned to arm 2Other
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 : active product (Thrombexx) | Active comparator | 100 patients will have the active product(Thrombexx), their visits on days 1,4,8 and 16 for target parameters assessment Receives: Drug: active product ( Thrombexx) assigned to arm 1 |
| Arm 2 : Placebo | Placebo comparator | 100 patients will have placebo , their visits on days 1,4,8 and 16 for target parameters assessment Receives: Other: Placebo assigned to arm 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of haematoma
Assessment the size of haematoma will be by ruler with unit centimeter(cm) , The ruler will measure the longest 2 intersecting line.
Measured: 6 months
Size of oedema
Assessment the size of oedema will be by measurement the circumference in unit centimeter(cm).
Measured: 6 months
Severity of Pain
Assessment of pain severity will be by Vas score
Measured: 6 months
Change in Colour
Assessment of colour will be by colour grade scale , A=Bluish red , B=Blue ,C= Faint
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2014 (estimated)
- Study completionApr 2014 (estimated)
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 r-Hirudin (Thrombexx) Efficacy in Treatment of HaematomasStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MinaPharm Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahmoud Hafez, Professor, Principal investigator, 6th October universityAhmed Moneer, Dr, Study chair, 6th october university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960569
- Sponsor's protocol ID
- Minpharm07052012
- Status last verified
- Oct 2013
- First submitted
- 7 Oct 2013
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
El-Mowafi H, El Araby A, Kandil Y, Zaghloul A. Randomized, double-blind, placebo-controlled, interventional phase IV investigation to assess the efficacy and safety of r-hirudin gel (1120I.U) in patients with hematomas. Res Pract Thromb Haemost. 2017 Nov 6;2(1):139-146. doi: 10.1002/rth2.12049. eCollection 2018 Jan.
PubMed 30046714
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Centre,Randomized,Phase IV Study to Assess the Topical r-Hirudin (Thrombexx)Efficacy in the Patients With Haematomas
- ClinicalTrials.gov ID
- NCT01960569
- Acronym / sponsor ID
- Minpharm07052012
- Keywords
- Thrombexx, Topical r-Hirudin, Efficacy, haematoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- MinaPharm PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 10 Oct 2013 (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.
Single centre ,Phase IV , interventional, The study includes :
200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo .
The patients will be randomized to the active product (arm 1) or to placebo (arm 2).
The study consists of 4 visits as the following :
- Visit 1 : on day 1 to check patient eligibility and also for randomization .
- Visit 2 : on day 4 to assess target parameters
- Visit 3 : on day 8 to assess target parameters
- Visit 4 : on day 16 to assess target parameters
Detailed description
Single centre ,Phase IV , interventional, The study includes :
- 200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo .
The patients will be randomized to the active product (arm 1) or to placebo (arm 2).
The study consists of 4 visits as the following :
- Visit 1 : on day 1 to check patient eligibility and also for randomization .
- Visit 2 : on day 4 to assess target parameters
- Visit 3 : on day 8 to assess target parameters
- Visit 4 : on day 16 to assess target parameters
- Study objective :Assessment the Efficacy of Topical r-Hirudin in treatment of haematomas ,also in resolving of the associated oedema
- Study duration : 6 months
- Selection of trial subjects:
Inclusion Criteria :
- Age of patients between 20 and 60 years old.
- Patients with all types of haematomas.
Exclusion Criteria:
- Presence of infected wound requiring hospitalization or surgical intervention.
- History of allergy or hypersensitivity to any of the ingredients.
- Patients with coagulation disorders like haemophilia.
- Patients who are on anticoagulants like Warfarin and Acetylsalicylic acid .
- Patients who are taking digestive enzymes like alfa chemotrypsin.
- Target parameters :
1.Size of haematoma.( Measured by ruler) , The ruler will measure the longest 2 intersecting line.
2.Size of oedema : by measurement of oedema circumference
3.Pain (by Vas score).
4.Change in colour ( by colour grade scale ) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 : active product (Thrombexx) | Active comparator | Drug: active product ( Thrombexx) assigned to arm 1100 patients will have the active product(Thrombexx), their visits on days 1,4,8 and 16 for target parameters assessment |
| Arm 2 : Placebo | Placebo comparator | Other: Placebo assigned to arm 2100 patients will have placebo , their visits on days 1,4,8 and 16 for target parameters assessment |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age of patients between 20 and 60 years old.
- Patients with all types of haematoma.
Key exclusion criteria (5 listed)
- Presence of infected wound requiring hospitalization or surgical intervention.
- History of allergy or hypersensitivity to any of the ingredients.
- Patients with coagulation disorders like haemophilia.
- Patients who are on anticoagulants like Warfarin and Acetylsalicylic acid .
- Patients who are taking digestive enzymes like alfa chemotrypsin.
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 |
|---|---|---|
| active product ( Thrombexx) assigned to arm 1Also: Topical r-HirudinDispense 2-3 cm of cream or gel, 2-3 times per day and carry out a light massage until complete | Drug | Arm 1 : active product (Thrombexx) |
| Placebo assigned to arm 2 | Other | Arm 2 : Placebo |
Primary outcome
Size of haematoma
Time frame: 6 months
Assessment the size of haematoma will be by ruler with unit centimeter(cm) , The ruler will measure the longest 2 intersecting line.
Size of oedema
Time frame: 6 months
Assessment the size of oedema will be by measurement the circumference in unit centimeter(cm).
Severity of Pain
Time frame: 6 months
Assessment of pain severity will be by Vas score
Change in Colour
Time frame: 6 months
Assessment of colour will be by colour grade scale , A=Bluish red , B=Blue ,C= Faint
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2013.
- Derived from this study: PubMed 30046714El-Mowafi H, El Araby A, Kandil Y, Zaghloul A. Randomized, double-blind, placebo-controlled, interventional phase IV investigation to assess the efficacy and safety of r-hirudin gel (1120I.U) in patients with hematomas. Res Pract Thromb Haemost. 2017 Nov 6;2(1):139-146. doi: 10.1002/rth2.12049. eCollection 2018 Jan.
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.
Mahmoud Hafez, Professor principal investigator
6th October university
Ahmed Moneer, Dr study chair
6th october university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing active product ( Thrombexx) assigned to arm 1 in people with r-Hirudin (Thrombexx) Efficacy in Treatment of Haematomas, run by MinaPharm Pharmaceuticals at 1 site in Egypt.
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 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: status not confirmed, as of the sponsor's last update on 10 Oct 2013. 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 Egypt. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Hafez, Professor (002 0100 7566299, mhafez@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of haematoma (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT01960569, 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 10 Oct 2013.