Trial · NCT02810444
Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID
NCT02810444, Phase 3, Completed, Biotest; results first posted 2023-07-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID. Trials, record NCT02810444. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02810444
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID
- NCT number
- NCT02810444
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 81 participants, actual
- Lead sponsor
- Biotest
- Conditions
- Primary Immunodeficiency Disease
- Interventions
- IgG Next Generation (BT595)
- First posted
- 2016-06-23
- Last updated
- 2023-07-20
- Other registries' IDs
- eudract:2015-003652-52
- Results first posted
- 2023-07-12
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Acute Serious Bacterial Infections | approx. 12 month treatment period | The primary efficacy endpoint was the rate of acute serious bacterial infections, ie, the mean number of acute serious bacterial infections \[SBIs as defined by EMA and FDA\] per subject-year. |
| Secondary | IgG Trough Levels (Total IgG) Before Each Infusion | approx. 12 month treatment period | Total IgG levels \[g/L\] before each infusion, mean (SD) |
| Secondary | Rate of Any Infections | approx. 12 month treatment period | The annual rate of infections was calculated as the number of all infections (serious plus nonserious) per subject-year |
| Secondary | Rate of Nonserious Infections | approx. 12 month treatment period | The annual rate of nonserious infections was calculated as the number of nonserious infections per subject-year |
| Secondary | Time to Resolution of Infections | approx. 12 month treatment period | Time to resolution of infections (days) was calculated as infection stop date - infection start date +1. |
| Secondary | Antibiotic Treatment Information | approx. 12 month treatment period | Median (min-max) number of days on antibiotics treatment per subject |
| Secondary | Rate of Time Lost From School/Work Due to Infections | approx. 12 month treatment period | Annual rates of the number of days subjects are not able to attend school/work due to infections and their treatment will be calculated per subject-year. |
| Secondary | Hospitalization / Hospitalization Due to Infection | approx. 12 month treatment period | Annual rates of the number of days of hospitalization (any hospitalization/ hospitalization due to infection) will be calculated per subject-year. |
| Secondary | Fever Episodes | approx. 12 month treatment period | The number of days with episodes of fever will be calculated as the number of fever episodes per subject-year. Fever is defined as a body temperature ≥38°C (≥100.4°F). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Acute Serious Bacterial Infections | approx. 12 month treatment period | The primary analysis intended to demonstrate that the SBI rate (upper limit of the 1-sided 99% CI) was \<1.0 per subject-year in the overall FAS | SBI rate per subject-year | NUMBER |
| SECONDARY | IgG Trough Levels (Total IgG) Before Each Infusion | approx. 12 month treatment period | Full analysis set | g/L | MEAN |
| SECONDARY | Rate of Any Infections | approx. 12 month treatment period | Full analysis set | infections per subject-year | NUMBER |
| SECONDARY | Rate of Nonserious Infections | approx. 12 month treatment period | Full analysis set | infections per subject-year | NUMBER |
| SECONDARY | Time to Resolution of Infections | approx. 12 month treatment period | Full analysis set | days | MEDIAN |
| SECONDARY | Antibiotic Treatment Information | approx. 12 month treatment period | Full analysis set | days | MEDIAN |
| SECONDARY | Rate of Time Lost From School/Work Due to Infections | approx. 12 month treatment period | Full analysis set | days per subject-year | NUMBER |
| SECONDARY | Hospitalization / Hospitalization Due to Infection | approx. 12 month treatment period | Full analysis set | days per subject-year | NUMBER |
| SECONDARY | Fever Episodes | approx. 12 month treatment period | Full analysis set | days per subject-year | NUMBER |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Acute Serious Bacterial Infections | BT595 | 0.015 | SBI rate per subject-year | ||
| IgG Trough Levels (Total IgG) Before Each Infusion | BT595 | Screening, Q4W | 8.467 | Standard Deviation 3.4562 | g/L |
| IgG Trough Levels (Total IgG) Before Each Infusion | BT595 | Baseline, Q4W | 7.824 | Standard Deviation 2.7705 | g/L |
| IgG Trough Levels (Total IgG) Before Each Infusion | BT595 | Infusion 1 (Week 0), Q4W | 7.824 | Standard Deviation 2.7705 | g/L |
| IgG Trough Levels (Total IgG) Before Each Infusion | BT595 | Infusion 2 (Week 4), Q4W | 8.278 | Standard Deviation 2.5919 | g/L |
| IgG Trough Levels (Total IgG) Before Each Infusion | BT595 | Infusion 3 (Week 8), Q4W | 8.246 | Standard Deviation 2.3970 | g/L |
| IgG Trough Levels (Total IgG) Before Each Infusion | BT595 | Infusion 4 (Week 12), Q4W | 8.410 | Standard Deviation 2.2998 | g/L |
| IgG Trough Levels (Total IgG) Before Each Infusion | BT595 | Infusion 5 (Week 16), Q4W | 8.634 | Standard Deviation 3.4997 | g/L |
| IgG Trough Levels (Total IgG) Before Each Infusion | BT595 | Infusion 6 (Week 20), Q4W | 8.203 | Standard Deviation 2.2912 | g/L |
| IgG Trough Levels (Total IgG) Before Each Infusion | BT595 | Infusion 7 (Week 24), Q4W | 8.298 | Standard Deviation 2.3822 | g/L |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BT595 | 81 | |
| Overall Study | Treatment Started | BT595 | 67 | |
| Overall Study | COMPLETED | BT595 | 60 | |
| Overall Study | NOT COMPLETED | BT595 | 21 |
Source ClinicalTrials.gov
Adverse events31
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | BT595 | 7 | 67 | 8 |
| other | Nausea | Gastrointestinal disorders | BT595 | 4 | 67 | 6 |
| other | Vomiting | Gastrointestinal disorders | BT595 | 4 | 67 | 4 |
| other | Fatigue | General disorders | BT595 | 6 | 67 | 10 |
| other | Bronchitis | Infections and infestations | BT595 | 8 | 67 | 12 |
| other | Conjunctivitis | Infections and infestations | BT595 | 4 | 67 | 6 |
| other | Influenza | Infections and infestations | BT595 | 6 | 67 | 6 |
| other | Nasopharyngitis | Infections and infestations | BT595 | 16 | 67 | 24 |
| other | Pharyngitis | Infections and infestations | BT595 | 7 | 67 | 8 |
| other | Sinusitis | Infections and infestations | BT595 | 8 | 67 | 11 |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BT595 | 0 | 67 |
| Total, other adverse events | BT595 | 63 | 67 |
| Total, serious adverse events | BT595 | 9 | 67 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02810444
GET https://conductscience.org/api/trials/v1/NCT02810444/results?page=2