A Phase 3 interventional study of Octagam 10% in Immune Thrombocytopenic Purpura, sponsored by Octapharma. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-01.
Sponsored by Octapharma · Phase 3, Interventional, and Treatment
Octagam is a solvent/detergent-treated human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in about 80 countries. This study evaluated the efficacy and safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura (ITP) in adults. As Octagam 10% is essentially similar to Octagam 5%, it is expected that Octagam 10% is as efficacious and safe (in respect to viral safety) as Octagam 5%.
The primary objective of the study was to investigate the efficacy of Octagam® 10% in correcting platelet count. The blood count as well as laboratory chemistry were checked repeatedly up to day 21.
The secondary objective of the study was to investigate the safety of Octagam® 10%. Safety was assessed by monitoring vital signs, evaluating adverse events, assessing laboratory parameters, and by viral safety testing.
263 studies on the registry are indexed under Purpura; 27 are open to participants now.
This study's enrollment of 116 is above the median of 50 across 171 interventional studies indexed under Purpura.
Browse Purpura studies →Octapharma is the lead sponsor of 69 studies on the registry; 8 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
Drug: Octagam 10%
Octagam 10% was supplied as a ready-to-use solution in glass bottles.
Also known as: Human normal immunoglobulin
Percentage of Participants With a Clinical Response
A clinical response is defined as an increase in platelet count to ≥ 50\*10\^9/L on any day from Day 2 to Day 7.
Time frame: Day 2 to Day 7
Time to Achieve a Clinical Response
A clinical response is defined as an increase in platelet count to ≥ 50\*10\^9/L on any day from Day 2 to Day 7.
Time frame: Day 2 to Day 7
Maximum Platelet Count
Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. The maximum measured platelet count is reported.
Time frame: Day 2 to the end of the study (Day 63)
Duration of the Clinical Response
The duration of the clinical response was the number of days that the platelet count remained ≥ 50\*10\^9/L. Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. A conservative method was used to calculate the duration of the clinical response. For example, if the platelet count was ≥ 50\*10\^9/L on Day 7 and dropped below 50\*10\^9/L at Day 14, Day 7 was used as the last day to calculate the duration of the clinical response. The same procedure was used if the platelet count dropped below 50\*10\^9/L at Day 21 from Day 14 or Day 63 from Day 21.
Time frame: Day 2 to the end of the study (Day 63)
Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7
The investigator evaluated the severity of bleeding using the following rating scale: None (definitely no haemorrhage of any kind), Minor (few petechiae \[≤ 100 total\] and/or ≤ 5 small bruises \[≤ 3 cm diameter\], no mucosal bleeding), Mild (many petechiae \[\> 100 total\] and/or \> 5 large bruises \[\> 3 cm diameter\], no mucosal bleeding), Moderate (overt mucosal bleeding \[epistaxis, gum bleeding, oropharyngeal blood blisters, menorrhagia, gastrointestinal bleeding, etc\] that does not require immediate medical attention or intervention).
Time frame: Day 7
| Milestone | Octagam 10% 1 g/kg/Day |
|---|---|
| Started | 116 |
| Completed | 110 |
| Not completed | 6 |
| Withdrew: Incorrectly enrolled in the study | 1 |
| Withdrew: Adverse event | 5 |
A clinical response is defined as an increase in platelet count to ≥ 50\*10\^9/L on any day from Day 2 to Day 7.
| Percentage of participants | Octagam 10% 1 g/kg/Day |
|---|---|
| Percentage of Participants With a Clinical Response | 80.0 |
A clinical response is defined as an increase in platelet count to ≥ 50\*10\^9/L on any day from Day 2 to Day 7.
| Days | Octagam 10% 1 g/kg/Day |
|---|---|
| Time to Achieve a Clinical Response | 2.1 ± 1.08 |
Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. The maximum measured platelet count is reported.
| *10^9/L | Octagam 10% 1 g/kg/Day |
|---|---|
| Maximum Platelet Count | 221.6 ± 142.66 |
The duration of the clinical response was the number of days that the platelet count remained ≥ 50\*10\^9/L. Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. A conservative method was used to calculate the duration of the clinical response. For example, if the platelet count was ≥ 50\*10\^9/L on Day 7 and dropped below 50\*10\^9/L at Day 14, Day 7 was used as the last day to calculate the duration of the clinical response. The same procedure was used if the platelet count dropped below 50\*10\^9/L at Day 21 from Day 14 or Day 63 from Day 21.
| Days | Octagam 10% 1 g/kg/Day |
|---|---|
| Duration of the Clinical Response | 24.1 ± 23.88 |
The investigator evaluated the severity of bleeding using the following rating scale: None (definitely no haemorrhage of any kind), Minor (few petechiae \[≤ 100 total\] and/or ≤ 5 small bruises \[≤ 3 cm diameter\], no mucosal bleeding), Mild (many petechiae \[\> 100 total\] and/or \> 5 large bruises \[\> 3 cm diameter\], no mucosal bleeding), Moderate (overt mucosal bleeding \[epistaxis, gum bleeding, oropharyngeal blood blisters, menorrhagia, gastrointestinal bleeding, etc\] that does not require immediate medical attention or intervention).
| Percentage of participants | Octagam 10% 1 g/kg/Day |
|---|---|
| None | 80.9 |
| Minor | 13.0 |
| Mild | 2.6 |
| Moderate | 0.9 |
| Missing | 2.6 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Octagam 10% 1 g/kg/Day | — | 14/116 (12.1%) | 79/116 (68.1%) |
| Event | Octagam 10% 1 g/kg/Day |
|---|---|
| Idiopathic thrombocytopenic purpuraBlood and lymphatic system disorders | 5/116 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/116 |
| HeadacheNervous system disorders | 2/116 |
| Extradural haematomaInjury, poisoning and procedural complications | 1/116 |
| InjuryInjury, poisoning and procedural complications | 1/116 |
| OverdoseInjury, poisoning and procedural complications | 1/116 |
| Transient ischaemic attackNervous system disorders | 1/116 |
| PneumoniaInfections and infestations | 1/116 |
| Platelet count decreasedInvestigations | 1/116 |
| Event | Octagam 10% 1 g/kg/Day |
|---|---|
| HeadacheNervous system disorders | 35/116 |
| Heart rate increasedInvestigations | 25/116 |
| PyrexiaGeneral disorders | 21/116 |
| Heart rate decreasedInvestigations | 18/116 |
| NauseaGastrointestinal disorders | 7/116 |
| HypertensionVascular disorders | 7/116 |
| Idiopathic thrombocytopenic purpuraBlood and lymphatic system disorders | 6/116 |
Safety population: All participants who received at least 1 dose of study medication.
| Age, Continuous(Years) | Octagam 10% 1 g/kg/Day |
|---|---|
| Mean | 47.7 ± 19.1 |
| Sex: Female, Male(Participants) | Octagam 10% 1 g/kg/Day |
|---|---|
| Female | 74 |
| Male | 42 |
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Octapharma