Trial · NCT04878731
Study to Evaluate Safety and Tolerability of a Single Dose of PF-06741086 in Chinese Adult Participants With Severe Hemophilia
NCT04878731, Phase 1, Completed, Pfizer; results first posted 2023-07-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Safety and Tolerability of a Single Dose of PF-06741086 in Chinese Adult Participants With Severe Hemophilia. Trials, record NCT04878731. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04878731
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Safety and Tolerability of a Single Dose of PF-06741086 in Chinese Adult Participants With Severe Hemophilia
- NCT number
- NCT04878731
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 6 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Severe Hemophilia
- Interventions
- PF-06741086
- First posted
- 2021-05-07
- Last updated
- 2023-07-07
- Results first posted
- 2023-07-07
Source ClinicalTrials.gov
Registered outcomes54
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Day 1 to Day 42 | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs that started during the effective duration of treatment regardless of whether a similar event existed at baseline. Grades of AEs were defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated;Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL);Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL;Grade 4=events with life-threatening consequences, urgent intervention indicated;Grade 5= death related to AE.Treatment-related TEAEs were determined by investigator. |
| Primary | Number of Participants With Serious Adverse Events (SAEs) | Day 1 to Day 42 | An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator. |
| Primary | Number of Participants With Maximum Grade 3 or 4 or 5 TEAEs | Day 1 to Day 42 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs that started during the effective duration of treatment regardless of whether a similar event existed in the baseline period. Grades of AEs were defined by NCI CTCAE version 5.0. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE. Treatment-related TEAEs were determined by the investigator. |
| Primary | Number of Participants With TEAEs Leading to Permanent or Temporary Discontinuation From Study | Day 1 to Day 42 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs that started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period. Grades of AEs were defined by NCI CTCAE version 5.0. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE. Treatment-related TEAEs were determined by the investigator. |
| Primary | Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | Day 1 to Day 28 | Laboratory assessments included chemistry, hematology, Prothrombin Time/International Normalized Ratio (PT/INR), Activated Partial Thromboplastin Time (APTT), urinalysis, fibrinogen, Antithrombin III (ATIII) activity, and Cardiac Troponin I (cTnI). Laboratory test abnormalities reported by at least 1 participant are reported in this outcome measure. ULN = upper limit of normal. |
| Primary | Mean Absolute Value of Prothrombin Time (PT) / International Normalized Ratio (INR) | Day 1, Day 2, Day 7, Day 14, Day 21, Day 28 | PT is one of the laboratory tests to evaluate the ability of blood clotting. The INR is derived from PT which is calculated as a ratio of a participant's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the World Health Organization (WHO) using the following formula: INR = Participant PT / Control PT. Blood samples were obtained to evaluate PT/INR. |
| Primary | Change From Baseline in PT/INR at Days 2, 7, 14, 21 and 28 | Baseline (Day 1), Day 2, Day 7, Day 14, Day 21, Day 28 | PT is one of the laboratory tests to evaluate the ability of blood clotting. The INR is derived from PT which is calculated as a ratio of a participant's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the WHO using the following formula: INR = Participant PT / Control PT. Blood samples were obtained to evaluate PT/INR. |
| Primary | Mean Absolute Value of Activated Partial Thromboplastin Time (APTT) | Day 1, Day 2, Day 7, Day 14, Day 21, Day 28 | The APTT is a screening test that helps evaluate a person's ability to appropriately form blood clots. It measures the number of seconds it takes for a clot to form in a sample of blood after substances (reagents) are added. Blood samples were obtained to evaluate APTT. |
| Primary | Change From Baseline in APTT at Days 2, 7, 14, 21 and 28 | Baseline (Day 1), Day 2, Day 7, Day 14, Day 21, Day 28 | The APTT is a screening test that helps evaluate a person's ability to appropriately form blood clots. It measures the number of seconds it takes for a clot to form in a sample of blood after substances (reagents) are added. Blood samples were obtained to evaluate APTT. |
| Primary | Mean Absolute Value of Fibrinogen | Day 1, Day 2, Day 7, Day 14, Day 21, Day 28 | Fibrinogen is a protein, specifically a clotting factor (factor I), that is essential for proper blood clot formation. Blood samples were obtained to evaluate the amount of fibrinogen. |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 registered outcomesOutcomes54
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Day 1 to Day 42 | The analysis population included all enrolled participants who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) | Day 1 to Day 42 | The analysis population included all enrolled participants who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Maximum Grade 3 or 4 or 5 TEAEs | Day 1 to Day 42 | The analysis population included all enrolled participants who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With TEAEs Leading to Permanent or Temporary Discontinuation From Study | Day 1 to Day 42 | The analysis population included all enrolled participants who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | Day 1 to Day 28 | The analysis population included all enrolled participants who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Mean Absolute Value of Prothrombin Time (PT) / International Normalized Ratio (INR) | Day 1, Day 2, Day 7, Day 14, Day 21, Day 28 | The analysis population included all enrolled participants who received at least 1 dose of study intervention. | ratio | MEAN |
| PRIMARY | Change From Baseline in PT/INR at Days 2, 7, 14, 21 and 28 | Baseline (Day 1), Day 2, Day 7, Day 14, Day 21, Day 28 | The analysis population included all enrolled participants who received at least 1 dose of study intervention. | Ratio | MEAN |
| PRIMARY | Mean Absolute Value of Activated Partial Thromboplastin Time (APTT) | Day 1, Day 2, Day 7, Day 14, Day 21, Day 28 | The analysis population included all enrolled participants who received at least 1 dose of study intervention. | second | MEAN |
| PRIMARY | Change From Baseline in APTT at Days 2, 7, 14, 21 and 28 | Baseline (Day 1), Day 2, Day 7, Day 14, Day 21, Day 28 | The analysis population included all enrolled participants who received at least 1 dose of study intervention. | Second | MEAN |
| PRIMARY | Mean Absolute Value of Fibrinogen | Day 1, Day 2, Day 7, Day 14, Day 21, Day 28 | The analysis population included all enrolled participants who received at least 1 dose of study intervention. | milligram per deciliter (mg/dL) | MEAN |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 outcomesResults by group299
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | All-Causality TEAEs | 1 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Treatment-Related TEAEs | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | All-Causality Severe TEAEs | 0 | Participants | |
| Number of Participants With Serious Adverse Events (SAEs) | PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | 0 | Participants | ||
| Number of Participants With Maximum Grade 3 or 4 or 5 TEAEs | PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | 0 | Participants | ||
| Number of Participants With TEAEs Leading to Permanent or Temporary Discontinuation From Study | PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | 0 | Participants | ||
| Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | APTT >1.1 x ULN | 6 | Participants | |
| Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Urine hemoglobin >=1 | 1 | Participants | |
| Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Urobilinogen >=1 | 2 | Participants | |
| Mean Absolute Value of Prothrombin Time (PT) / International Normalized Ratio (INR) | PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Day 1 | 1.000 | Standard Deviation 0.0790 | ratio |
1 to 10 of 299Source ClinicalTrials.gov
See all 299 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | 6 | |
| Overall Study | COMPLETED | PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | 6 | |
| Overall Study | NOT COMPLETED | PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | 0 |
Source ClinicalTrials.gov
Adverse events1
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 | Upper respiratory tract infection | Infections and infestations | PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | 1 | 6 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | 0 | 6 |
| Total, other adverse events | PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | 1 | 6 |
| Total, serious adverse events | PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | 0 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42698050 | DERIVED |
Source PubMed
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/NCT04878731
GET https://conductscience.org/api/trials/v1/NCT04878731/registered?page=2