A Study of Efficacy and Safety of FXS6837 in Anti-C5 Treated PNH Patients.
NCT07914894, Phase 3, Not yet recruiting, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study of Efficacy and Safety of FXS6837 in Anti-C5 Treated PNH Patients. | ClinicalTrials.gov |
| NCT number | NCT07914894 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 20 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | ClinicalTrials.gov |
| Conditions | Paroxysmal Nocturnal Hemoglobinuria | ClinicalTrials.gov |
| Interventions | FXS6837 Capsule | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of participants with hemoglobin (Hb) level ≥ 120 g/L in at least 3 of 4 measurements between Week18 and Week24 in the absence of RBC transfusion (defined as no RBC transfusion after Week2 through Week24) | 24 weeks from Baseline (Week 18 through Week 24) | ClinicalTrials.gov | |
| Secondary | Proportion of participants with an increase from baseline in Hb level of ≥ 20 g/L in at least 3 of 4 measurements between Week18 and Week24 in the absence of RBC transfusion (defined as no RBC transfusion after Week2 through Week24) | 24 weeks from Baseline (Baseline, Week 18 through Week 24) | ClinicalTrials.gov | |
| Secondary | Proportion of participants without RBC transfusion during the treatment period from between Week2 to Week24 | Week2 to Week24 | ClinicalTrials.gov | |
| Secondary | Change from baseline in Hb as mean of visits between Week18 and Week24 | 24 weeks from Baseline (Baseline, Week 18 through Week 24) | ClinicalTrials.gov | |
| Secondary | Change from baseline in reticulocyte count during the treatment period from Week18 to Week24 | 24 weeks from Baseline (Baseline, Week 18 through Week 24) | ClinicalTrials.gov | |
| Secondary | Percent change from baseline in lactate dehydrogenase (LDH) levels during the treatment period from Week18 to Week24 | 24 weeks from Baseline(Baseline, Week 18 through Week 24) | ClinicalTrials.gov | |
| Secondary | Proportion of participants with LDH ≤ 1.5 × upper limit of normal (ULN) in at least 3 of 4 measurements between Week18 and Week24; | 24 weeks from Baseline (Week 18 through Week 24) | ClinicalTrials.gov | |
| Secondary | Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) score during the treatment period from Week18 to Week24 | 24 weeks from Baseline (Baseline, Week 18 through Week 24) | ClinicalTrials.gov | |
| Secondary | Incidence rate of BTH between Week1 and Week24 | up to 24 weeks | ClinicalTrials.gov | |
| Secondary | Incidence of MAVEs between Week1 and Week24 | up to 24 weeks | ClinicalTrials.gov | |
| Secondary | Safety evaluation: All participants will be observed for any adverse event (AE) during the clinical study. | up to 24 weeks | ClinicalTrials.gov | |
| Secondary | Population Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of FXS6837 | From pre-dose on Day1 to Week24 | ClinicalTrials.gov | |
| Secondary | Population Pharmacokinetics (PK): Plasma trough concentration (Ctrough) of FXS6837 | From pre-dose on Day1 to Week24 | ClinicalTrials.gov | |
| Secondary | Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of FXS6837 | From pre-dose on Day1 to Week24 | ClinicalTrials.gov | |
| Secondary | The exposure-response correlation between Steady-State trough Concentration (Ctrough) of FXS6837 and hemoglobin (Hb) level | From pre-dose on Day1 to Week24 | ClinicalTrials.gov | |
| Secondary | The exposure-response correlation between Steady-State trough Concentration (Ctrough) of FXS6837 and lactate dehydrogenase (LDH) level | From pre-dose on Day1 to Week24 | ClinicalTrials.gov | |
| Secondary | The exposure-response correlation between Steady-State trough Concentration (Ctrough) of FXS6837 and Alternative Pathway(AP) activity | From pre-dose on Day1 to Week24 | ClinicalTrials.gov | |
| Secondary | The exposure-response correlation between Steady-State trough Concentration (Ctrough) of FXS6837 and Fragment Bb of Complement Factor B level | From pre-dose on Day1 to Week24 | ClinicalTrials.gov | |
| Secondary | The exposure-response correlation between Steady-State trough Concentration (Ctrough) of FXS6837 and soluble C5b-9 (sC5b-9) level | From pre-dose on Day1 to Week24 | ClinicalTrials.gov | |
| Secondary | The exposure-response correlation between Steady-State trough Concentration (Ctrough) of FXS6837 and PNH granulocyte clone percentage | From pre-dose on Day1 to Week24 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)