Trial · NCT02591862
Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH)
NCT02591862, Phase 2, Completed, AKARI Therapeutics; results first posted 2023-07-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH). Trials, record NCT02591862. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02591862
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH)
- NCT number
- NCT02591862
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- AKARI Therapeutics
- Conditions
- Paroxysmal Nocturnal Haemoglobinuria (PNH)
- Interventions
- Coversin
- First posted
- 2015-10-30
- Last updated
- 2023-07-12
- Results first posted
- 2023-07-12
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Measurement of Ratio of LDH to the Upper Limit of Normal (ULN) | Day 0 and Day 28 | LDH is an indicator of disease progression in patients with PNH and is expected to fall to within 2x upper limit of normal (ULN) within 28 days in successfully treated patients. Units are measured in ratio of LDH:ULN, where the ULN is 250 U/L. The primary efficacy endpoint was the LDH AUC from Day 0 to 28 compared with 28 days pretreatment. Data for the 28 days pre-treatment was not collected, and as only one patient was recruited, the LDH values compared with baseline and the ratio of LDH to the Upper Limit of Normal (ULN) are presented. |
| Primary | Number and Type of Adverse Events (AE) | 2 years | The number and type of reported AEs will be recorded as well as the opinion of the Principle Investigator (PI) as to their possible relationship to the study drug. |
| Secondary | Measurement of Haemoglobin (Hb) at Days 28, 90, and 180, Absolute and Change From Baseline | Baseline, Day 28, Day 90 and Day 180 | Measuring change in mean Hb from Day 28, Day 90 and Day 180 (absolute and change from baseline) |
| Secondary | Measurement of Haptoglobin (Hp) at Days 28, 90 and 180, Absolute and Change From Baseline | Baseline, Day 28, Day 90 and Day 180 | Measuring change in mean Hp from Day 28, Day 90 and Day 180 (absolute and change from baseline) |
| Secondary | Measurement of Lactate Dehydrogenase (LDH) at Baseline, Day 90 and Day 180 | Baseline, Day 90 and Day 180 | Measuring the change in LDH at Baseline, Day 90 and Day 180. LDH is an indicator of disease progression in patients with PNH and is expected to fall to within 2x upper limit of normal (ULN) within 28 days in successfully treated patients. Units are measured in ratio of LDH:ULN, where the ULN is 250 U/L. |
| Secondary | Change in Functional Assessment of Chronic Illness Therapy (FACIT) Score at Days 0, 28, 90 and 180 | Day 28, 90 and 180 | Functional Assessment of Chronic Illness Therapy - fatigue (FACIT-F) is a 13 item instrument designed to assess fatigue/tiredness and it's impact on daily activities and functioning in a chronic disease setting. The scale for each question in relation to quality of life ranges from 0-4 where 0= not at all, 1= a little bit, 2= somewhat, 3 = quite a bit and 4= very much. An increase in the scale score indicates an improvement in quality of life (less fatigue). A maximum score of 52 is interpreted as no fatigue . Baseline is assumed as 0.0 to demonstrate the change in units. The subscale score (as presented) is determined as per FACIT-f guidance, by multiplying the sum of the item scores by the number of items in the subscale, then divide by the number of items answered. |
| Secondary | Change in Quality Of Life Questionnaire (QOQ) Score at Days 0, 28, 90 and 180 | Day 28, 90 and 180 | The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 instrument measures the change in the quality of of life of patients in the trial. It comprises 30 questions on daily QOL and incorporates a global health status, five functional scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, nausea/vomiting, pain), and six single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties). All of the scales range in score from 0 to 100, A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. Scale scores were calculated by averaging items within scales and transforming average scores linearly. |
| Secondary | Dependency on Blood Transfusion | Day 0 through to study completion (2 years) | Number of participants depending on blood transfusion prior to starting the study compared to during the study. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Measurement of Ratio of LDH to the Upper Limit of Normal (ULN) | Day 0 and Day 28 | Single arm trial design, results from 1 enrolled participant. | Ratio of LDH:ULN (250 U/L) | NUMBER |
| PRIMARY | Number and Type of Adverse Events (AE) | 2 years | Results from 1 enrolled participant. | Events | NUMBER |
| SECONDARY | Measurement of Haemoglobin (Hb) at Days 28, 90, and 180, Absolute and Change From Baseline | Baseline, Day 28, Day 90 and Day 180 | Results from 1 enrolled participant. | millimole(s)/litre | NUMBER |
| SECONDARY | Measurement of Haptoglobin (Hp) at Days 28, 90 and 180, Absolute and Change From Baseline | Baseline, Day 28, Day 90 and Day 180 | Results from 1 enrolled participant. | gram(s)/litre | NUMBER |
| SECONDARY | Measurement of Lactate Dehydrogenase (LDH) at Baseline, Day 90 and Day 180 | Baseline, Day 90 and Day 180 | Single arm trial design, results from 1 enrolled participant. | Ratio of LDH:ULN (250 U/L) | NUMBER |
| SECONDARY | Change in Functional Assessment of Chronic Illness Therapy (FACIT) Score at Days 0, 28, 90 and 180 | Day 28, 90 and 180 | FACIT-f scale (Change from Baseline) | NUMBER | |
| SECONDARY | Change in Quality Of Life Questionnaire (QOQ) Score at Days 0, 28, 90 and 180 | Day 28, 90 and 180 | Single arm trial design, results from 1 enrolled participant. | Scores on a scale (Change from baseline) | NUMBER |
| SECONDARY | Dependency on Blood Transfusion | Day 0 through to study completion (2 years) | Results from 1 enrolled participant. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Measurement of Ratio of LDH to the Upper Limit of Normal (ULN) | Coversin | Day 0 | 5.6 | Ratio of LDH:ULN (250 U/L) | |
| Measurement of Ratio of LDH to the Upper Limit of Normal (ULN) | Coversin | Day 28 | 1.9 | Ratio of LDH:ULN (250 U/L) | |
| Number and Type of Adverse Events (AE) | Coversin | Serious Adverse Events (SAE) | 2 | Events | |
| Number and Type of Adverse Events (AE) | Coversin | Adverse Event (AE) (total) | 20 | Events | |
| Number and Type of Adverse Events (AE) | Coversin | Treatment Emergent Adverse Event (TAEA) | 13 | Events | |
| Number and Type of Adverse Events (AE) | Coversin | AE - moderate | 1 | Events | |
| Number and Type of Adverse Events (AE) | Coversin | AE - severe | 1 | Events | |
| Number and Type of Adverse Events (AE) | Coversin | AE- mild | 18 | Events | |
| Measurement of Haemoglobin (Hb) at Days 28, 90, and 180, Absolute and Change From Baseline | Coversin | Baseline | 8.2 | millimole(s)/litre | |
| Measurement of Haemoglobin (Hb) at Days 28, 90, and 180, Absolute and Change From Baseline | Coversin | Day 28 (absolute) | 7.8 | millimole(s)/litre |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Coversin | 1 | |
| Overall Study | COMPLETED | Coversin | 1 | |
| Overall Study | NOT COMPLETED | Coversin | 0 |
Source ClinicalTrials.gov
Adverse events20
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 | Abdominal pain | Gastrointestinal disorders | Coversin | 1 | 1 | 2 |
| other | Nausea | Gastrointestinal disorders | Coversin | 1 | 1 | 1 |
| other | Cough | General disorders | Coversin | 1 | 1 | 1 |
| other | Fatigue | General disorders | Coversin | 1 | 1 | 1 |
| other | Flu like symptoms | General disorders | Coversin | 1 | 1 | 5 |
| other | Injection site Reaction | General disorders | Coversin | 1 | 1 | 13 |
| other | Malaise | General disorders | Coversin | 1 | 1 | 2 |
| other | Non-cardiac chest pain | General disorders | Coversin | 1 | 1 | 1 |
| other | Papulopustular rash | Infections and infestations | Coversin | 1 | 1 | 1 |
| other | Headache | Nervous system disorders | Coversin | 1 | 1 | 6 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Coversin | 0 | 1 |
| Total, other adverse events | Coversin | 1 | 1 |
| Total, serious adverse events | Coversin | 1 | 1 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31840801 | RESULT |
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/NCT02591862
GET https://conductscience.org/api/trials/v1/NCT02591862/results?page=2