Trial Outcomes & Findings for Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients (NCT NCT01712438)
NCT ID: NCT01712438
Last Updated: 2021-01-19
Results Overview
The number of patients developing FVIII inhibitors was observed during the observation period by assessing inhibitor development using the modified Bethesda assay (Nijmegen modification). The definitions for thresholds were ≥0.6 to \<5 BU/mL for a "low titre" inhibitor and ≥5 BU/mL for a "high-titre" inhibitor.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
110 participants
Primary outcome timeframe
maximum 5 years (100 exposure days)
Results posted on
2021-01-19
Participant Flow
Participant milestones
| Measure |
Human-cl rhFVIII
Of the total number of patients that started in the study, the safety (SAF) and intent-to-treat (ITT) population received at least one treatment with Human-cl rhFVIII.
Prophylactic treatment dose given to all patients in the PROPH population (all patients who received at least one administration of Human cI rhFVIII with prophylaxis documented as the reason for treatment): 20-50 IU/FVIII/kg body weight (BW)).
On-demand treatment of bleeding episodes (BEs) dose given to the BLEED population (all patients with bleeding episodes treated with Human cI rhFVIII): 20-30 IU FVIII/kg BW (minor haemorrhage), 30-40 IU FVIII/kg BW (moderate to major haemorrhage) or 40-60 IU FVIII/kg BW (major to life-threatening haemorrhage). Surgical prophylaxis dose given to the SURG population (all patients with surgeries performed under Human cI rhFVIII treatment): 25-30 IU FVIII/kg BW (minor surgeries) or 40-60 IU FVIII/kg BW (major surgeries).
|
|---|---|
|
Overall Study
STARTED
|
110
|
|
Overall Study
SAF Population
|
108
|
|
Overall Study
ITT Population
|
108
|
|
Overall Study
PP Population
|
95
|
|
Overall Study
PROPH Population
|
103
|
|
Overall Study
BLEED Population
|
94
|
|
Overall Study
SURG Population
|
24
|
|
Overall Study
COMPLETED
|
73
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
Human-cl rhFVIII
Of the total number of patients that started in the study, the safety (SAF) and intent-to-treat (ITT) population received at least one treatment with Human-cl rhFVIII.
Prophylactic treatment dose given to all patients in the PROPH population (all patients who received at least one administration of Human cI rhFVIII with prophylaxis documented as the reason for treatment): 20-50 IU/FVIII/kg body weight (BW)).
On-demand treatment of bleeding episodes (BEs) dose given to the BLEED population (all patients with bleeding episodes treated with Human cI rhFVIII): 20-30 IU FVIII/kg BW (minor haemorrhage), 30-40 IU FVIII/kg BW (moderate to major haemorrhage) or 40-60 IU FVIII/kg BW (major to life-threatening haemorrhage). Surgical prophylaxis dose given to the SURG population (all patients with surgeries performed under Human cI rhFVIII treatment): 25-30 IU FVIII/kg BW (minor surgeries) or 40-60 IU FVIII/kg BW (major surgeries).
|
|---|---|
|
Overall Study
Not treated with Human-cl rhFVIII
|
2
|
|
Overall Study
Ongoing ITI treatment
|
6
|
|
Overall Study
Violated inclusion & exclusion criteria
|
4
|
|
Overall Study
Prematurely Discontinued
|
25
|
Baseline Characteristics
Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients
Baseline characteristics by cohort
| Measure |
Human-cl rhFVIII
n=108 Participants
The safety (SAF) and intent-to-treat (ITT) population consists all patients who had data collected post-treatment with Human-cl rhFVIII (n=108).
|
|---|---|
|
Age, Continuous
|
21.6 months
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
105 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
|
Body Mass Index (BMI) at Exposure Day 1 (ED1)
|
17.2 kg/m2
n=93 Participants
|
|
Height at Exposure Day 1 (ED1)
|
82.0 centimeters (cm)
n=93 Participants
|
|
Weight at Exposure Day 1 (ED1)
|
11.7 kilograms (kg)
n=93 Participants
|
|
Family history of inhibitors
Yes
|
13 Participants
n=93 Participants
|
|
Family history of inhibitors
No
|
95 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: maximum 5 years (100 exposure days)Population: The analysis was performed for the SAF/ITT population which includes all patients who had data collected post-treatment with Human-cl rhFVIII (n=108). Of the 108 patients, 105 patients had at least one inhibitor test after exposure day (ED) 1.
The number of patients developing FVIII inhibitors was observed during the observation period by assessing inhibitor development using the modified Bethesda assay (Nijmegen modification). The definitions for thresholds were ≥0.6 to \<5 BU/mL for a "low titre" inhibitor and ≥5 BU/mL for a "high-titre" inhibitor.
Outcome measures
| Measure |
SAF/ITT Population
n=105 Participants
All patients who had data collected post-treatment with Human-cl rhFVIII (n=108).
|
Major Surgeries
All patients that had major surgeries performed under Human-cl rhFVIII treatment (n=11)
|
All Surgeries
All patients that had surgeries performed under Human-cl rhFVIII treatment (n=24)
|
|---|---|---|---|
|
Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors
High titre inhibitor (>5 BU/mL)
|
17 Participants
|
—
|
—
|
|
Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors
Low titre inhibitor (<5 BU/mL)
|
11 Participants
|
—
|
—
|
|
Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors
Any inhibitor (>0.6 BU/mL)
|
28 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Maximum 5 years (100 exposure days)Population: The analysis population includes all patients who received at least one prophylactic treatment with Human-cl rhFVIII (PROPH population; n=103). Of all patients in the PROPH population, data was available on spontaneous break-through bleeds for 102 patients.
The annualized bleeding rate (ABR) was calculated during inhibitor-free periods for spontaneous bleeding events (BEs) during prophylactic treatment with Human cl rhFVIII
Outcome measures
| Measure |
SAF/ITT Population
n=102 Participants
All patients who had data collected post-treatment with Human-cl rhFVIII (n=108).
|
Major Surgeries
All patients that had major surgeries performed under Human-cl rhFVIII treatment (n=11)
|
All Surgeries
All patients that had surgeries performed under Human-cl rhFVIII treatment (n=24)
|
|---|---|---|---|
|
Frequency of Spontaneous Break-through Bleeds
|
0.976 No. BEs per duration (year) (ABR)
Interval 0.431 to 1.521
|
—
|
—
|
SECONDARY outcome
Timeframe: Maximum 5 years (100 exposure days)Population: The analysis population includes patients (n=94) who received Human-cl rhFVIII for on-demand treatment of BEs (BLEED population).
A personal efficacy assessment to assess the efficacy of Human-cl rhFVIII for the on-demand treatment of bleeding episodes. Efficacy was assessed using a four-point scale (excellent, good, moderate, none).
Outcome measures
| Measure |
SAF/ITT Population
n=804 Number of Bleeding Events
All patients who had data collected post-treatment with Human-cl rhFVIII (n=108).
|
Major Surgeries
All patients that had major surgeries performed under Human-cl rhFVIII treatment (n=11)
|
All Surgeries
All patients that had surgeries performed under Human-cl rhFVIII treatment (n=24)
|
|---|---|---|---|
|
Efficacy of Human-cl rhFVIII for the Treatment of Bleeds
Excellent
|
510 Number of Bleeding Events
|
—
|
—
|
|
Efficacy of Human-cl rhFVIII for the Treatment of Bleeds
Good
|
237 Number of Bleeding Events
|
—
|
—
|
|
Efficacy of Human-cl rhFVIII for the Treatment of Bleeds
Moderate
|
51 Number of Bleeding Events
|
—
|
—
|
|
Efficacy of Human-cl rhFVIII for the Treatment of Bleeds
None
|
6 Number of Bleeding Events
|
—
|
—
|
SECONDARY outcome
Timeframe: Maximum 5 years (100 exposure days)Population: The analysis population includes 24 patients that received Human-cl rhFVIII for surgical prophylaxis during a total of 26 surgeries (SURG population). Of these, 13 patients had minor surgeries and 11 patients had major surgeries. Of the total 26 surgeries, 21 had an overall efficacy assessment (an assessment was not performed for 5 surgeries).
An overall efficacy assessment to assess the efficacy of human-cl rhFVIII in surgical prophylaxis of minor and major surgeries. The efficacy assessment was analyzed using a four-point scale (excellent, good, moderate, none).
Outcome measures
| Measure |
SAF/ITT Population
n=10 Number of surgeries
All patients who had data collected post-treatment with Human-cl rhFVIII (n=108).
|
Major Surgeries
n=11 Number of surgeries
All patients that had major surgeries performed under Human-cl rhFVIII treatment (n=11)
|
All Surgeries
n=21 Number of surgeries
All patients that had surgeries performed under Human-cl rhFVIII treatment (n=24)
|
|---|---|---|---|
|
Efficacy of Human-cl rhFVIII for Surgical Prophylaxis
Excellent
|
7 Number of surgeries
|
8 Number of surgeries
|
15 Number of surgeries
|
|
Efficacy of Human-cl rhFVIII for Surgical Prophylaxis
Good
|
1 Number of surgeries
|
2 Number of surgeries
|
3 Number of surgeries
|
|
Efficacy of Human-cl rhFVIII for Surgical Prophylaxis
Moderate
|
1 Number of surgeries
|
1 Number of surgeries
|
2 Number of surgeries
|
|
Efficacy of Human-cl rhFVIII for Surgical Prophylaxis
None
|
1 Number of surgeries
|
0 Number of surgeries
|
1 Number of surgeries
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 yearsPopulation: Of the 110 patients enrolled in the study, 2 were excluded because they had no treatment with Human-cl rhFVIII leaving 108 patients in the safety (SAF) and intent-to-treat (ITT) population.
The frequency of AEs, as monitored throughout the whole study by the number of patients with at least one adverse event occurrence.
Outcome measures
| Measure |
SAF/ITT Population
n=108 Participants
All patients who had data collected post-treatment with Human-cl rhFVIII (n=108).
|
Major Surgeries
All patients that had major surgeries performed under Human-cl rhFVIII treatment (n=11)
|
All Surgeries
All patients that had surgeries performed under Human-cl rhFVIII treatment (n=24)
|
|---|---|---|---|
|
The Occurrence of Any Adverse Event (AE)
Adverse Event (AE)
|
101 Participants
|
—
|
—
|
|
The Occurrence of Any Adverse Event (AE)
Serious adverse event (SAE)
|
48 Participants
|
—
|
—
|
|
The Occurrence of Any Adverse Event (AE)
Severe AE
|
27 Participants
|
—
|
—
|
|
The Occurrence of Any Adverse Event (AE)
Temporally related adverse event
|
78 Participants
|
—
|
—
|
|
The Occurrence of Any Adverse Event (AE)
Death
|
0 Participants
|
—
|
—
|
|
The Occurrence of Any Adverse Event (AE)
Death due to probably/possibly related AE
|
0 Participants
|
—
|
—
|
|
The Occurrence of Any Adverse Event (AE)
AE leading to permanent study discontinuation
|
2 Participants
|
—
|
—
|
Adverse Events
SAF/ITT Population
Serious events: 48 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SAF/ITT Population
n=108 participants at risk
All patients who had data collected post-treatment with Human-cl rhFVIII (n=108).
|
|---|---|
|
Blood and lymphatic system disorders
Factor VIII inhibition
|
25.9%
28/108 • Number of events 29 • Maximum 5 years (100 exposure days)
|
|
Vascular disorders
Haematoma
|
3.7%
4/108 • Number of events 4 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Tonsillitis
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
General disorders
Pyrexia
|
4.6%
5/108 • Number of events 8 • Maximum 5 years (100 exposure days)
|
|
Injury, poisoning and procedural complications
Injury
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Injury, poisoning and procedural complications
Head injury
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Pneumonia
|
1.9%
2/108 • Number of events 2 • Maximum 5 years (100 exposure days)
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Bronchitis
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Staphylococcal infection
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Product Issues
Device Issue
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Gastroenteritis
|
1.9%
2/108 • Number of events 2 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Nasopharyngitis
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Blood and lymphatic system disorders
Factor IX inhibition
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
1.9%
2/108 • Number of events 2 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Device related sepsis
|
1.9%
2/108 • Number of events 3 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Device related infection
|
1.9%
2/108 • Number of events 2 • Maximum 5 years (100 exposure days)
|
|
Gastrointestinal disorders
Ileus
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Ear infection
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Influenza
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
1.9%
2/108 • Number of events 2 • Maximum 5 years (100 exposure days)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Septic shock
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Fungal skin infection
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Injury, poisoning and procedural complications
Fall
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Injury, poisoning and procedural complications
Scrotal haematoma
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.93%
1/108 • Number of events 2 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Gastrointestinal infection
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Periodontitis
|
0.93%
1/108 • Number of events 1 • Maximum 5 years (100 exposure days)
|
Other adverse events
| Measure |
SAF/ITT Population
n=108 participants at risk
All patients who had data collected post-treatment with Human-cl rhFVIII (n=108).
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
32.4%
35/108 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Rhinitis
|
18.5%
20/108 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
12/108 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Ear infection
|
10.2%
11/108 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Bronchitis
|
9.3%
10/108 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Conjunctivitis
|
8.3%
9/108 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Gastroenteritis
|
8.3%
9/108 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Varicella
|
7.4%
8/108 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Respiratory tract infection
|
6.5%
7/108 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Laryngitis
|
5.6%
6/108 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Pharyngitis
|
4.6%
5/108 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Tonsillitis
|
4.6%
5/108 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Lower respiratory tract infection
|
3.7%
4/108 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Pneumonia
|
3.7%
4/108 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Device related information
|
2.8%
3/108 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Erythema infectiosum
|
2.8%
3/108 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Influenza
|
2.8%
3/108 • Maximum 5 years (100 exposure days)
|
|
Infections and infestations
Viral infection
|
2.8%
3/108 • Maximum 5 years (100 exposure days)
|
|
General disorders
Pyrexia
|
56.5%
61/108 • Maximum 5 years (100 exposure days)
|
|
Blood and lymphatic system disorders
Factor VIII inhibition
|
25.9%
28/108 • Maximum 5 years (100 exposure days)
|
|
Blood and lymphatic system disorders
Anaemia
|
19.4%
21/108 • Maximum 5 years (100 exposure days)
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
2.8%
3/108 • Maximum 5 years (100 exposure days)
|
|
Gastrointestinal disorders
Diarrhoea
|
13.0%
14/108 • Maximum 5 years (100 exposure days)
|
|
Gastrointestinal disorders
Teething
|
9.3%
10/108 • Maximum 5 years (100 exposure days)
|
|
Gastrointestinal disorders
Vomiting
|
9.3%
10/108 • Maximum 5 years (100 exposure days)
|
|
Gastrointestinal disorders
Constipation
|
4.6%
5/108 • Maximum 5 years (100 exposure days)
|
|
Gastrointestinal disorders
Toothache
|
3.7%
4/108 • Maximum 5 years (100 exposure days)
|
|
Gastrointestinal disorders
Stomatitis
|
2.8%
3/108 • Maximum 5 years (100 exposure days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.9%
15/108 • Maximum 5 years (100 exposure days)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.8%
3/108 • Maximum 5 years (100 exposure days)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
2.8%
3/108 • Maximum 5 years (100 exposure days)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.8%
3/108 • Maximum 5 years (100 exposure days)
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
12/108 • Maximum 5 years (100 exposure days)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
2.8%
3/108 • Maximum 5 years (100 exposure days)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.8%
3/108 • Maximum 5 years (100 exposure days)
|
|
Injury, poisoning and procedural complications
Head injury
|
5.6%
6/108 • Maximum 5 years (100 exposure days)
|
|
Injury, poisoning and procedural complications
Mouth injury
|
2.8%
3/108 • Maximum 5 years (100 exposure days)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.7%
4/108 • Maximum 5 years (100 exposure days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
3/108 • Maximum 5 years (100 exposure days)
|
|
Investigations
Haemoglobin decreased
|
3.7%
4/108 • Maximum 5 years (100 exposure days)
|
|
Metabolism and nutrition disorders
Iron deficiency
|
3.7%
4/108 • Maximum 5 years (100 exposure days)
|
|
Immune system disorders
Hypersensitivity
|
2.8%
3/108 • Maximum 5 years (100 exposure days)
|
|
Vascular disorders
Haematoma
|
4.6%
5/108 • Maximum 5 years (100 exposure days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Octapharma agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Octapharma supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial. Octapharma also reserves the right to review data prior to publishing and provide comments/changes within a certain time period.
- Publication restrictions are in place
Restriction type: OTHER