A Phase 2 interventional study of Coversin in Paroxysmal Nocturnal Hemoglobinuria (PNH), sponsored by AKARI Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by AKARI Therapeutics · Phase 2, Interventional, and Treatment
Coversin in Paroxysmal Nocturnal Hemoglobinuria (PNH) in patients with resistance to Eculizumab due to complement C5 polymorphisms.
Coversin, a small protein complement C5 inhibitor which prevents the cleavage of C5 by C5 convertase into C5a and C5b, will be used in an open label, non-comparative clinical trial in patients with PNH and proven resistance to eculizumab due to C5 polymorphisms. Patients will be treated with Coversin by daily subcutaneous injection for 6 months in order to determine the safety and efficacy of the drug in these circumstances. If satisfactory control of the PNH is achieved, and at the discretion of the Principal Investigator (PI), patients will have the option of remaining on Coversin and being entered into the long term follow-up study.
191 studies on the registry are indexed under Hemoglobinuria, Paroxysmal; 49 are open to participants now.
This study's enrollment of 1 is below the median of 33 across 150 interventional studies indexed under Hemoglobinuria, Paroxysmal.
Browse Hemoglobinuria, Paroxysmal studies →AKARI Therapeutics is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Coversin - 22.5mg followed by 45mg for 6 months.
Drug: Coversin
Coversin - 22.5mg followed by 45mg for 6 months.
Measurement of Serum Lactate Dehydrogenase (LDH)
Measurement of serum lactate dehydrogenase (LDH)
Time frame: Baseline to Day 186
Percentage Change in Haemoglobin (Hb) Compared to Screening
Percentage change in the haemoglobin (Hb) value at each study visit compared to screening
Time frame: Baseline to Day 186
Number of Packed Red Blood Cells (PRBC) Transfusions
Number of units of packed red blood cells (PRBC) transfusions
Time frame: Baseline to Day 180
Patients with paroxysmal nocturnal hemoglobinuria (PNH) who had received eculizumab without apparent benefit and in whom it had been demonstrated that their serum was resistant to eculizumab at any concentration (due to complement C5 polymorphisms that prevent tight binding of eculizumab) were recruited from one medical center between May 2018 and February 2021.
| Milestone | Coversin Treatment |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
Measurement of serum lactate dehydrogenase (LDH)
| U/L | Coversin Treatment |
|---|---|
| Screening | 2913 |
| Day 1 | 3056 |
| Day 3 | 1453 |
| Day 7 | 564 |
| Day 14 | 351 |
| Day 21 | 368 |
| Day 29 | 329 |
| Day 36 | 339 |
| Day 43 | 555 |
| Day 60 | 319 |
| Day 90 | 394 |
| Day 120 | 352 |
| Day 150 | 284 |
| Day 183 | 906 |
| Day 184 | 882 |
| Day 186 | 612 |
Percentage change in the haemoglobin (Hb) value at each study visit compared to screening
| %change in Hb value compare to screening | Coversin Treatment |
|---|---|
| Screening | 0 |
| Day 1 | 28 |
| Day 3 | 18 |
| Day 7 | 22 |
| Day 14 | 17 |
| Day 21 | 25 |
| Day 29 | 23 |
| Day 36 | 9 |
| Day 43 | 26 |
| Day 60 | 60 |
| Day 90 | 28 |
| Day 120 | 18 |
| Day 150 | 23 |
| Day 186 | 26 |
Number of units of packed red blood cells (PRBC) transfusions
| PRBC Units | Coversin Treatment |
|---|---|
| Day -35 | 1 |
| Day -10 | 2 |
| Day 38 | 1 |
| Day 39 | 2 |
Collected over All adverse events were collected from the time of informed consent until completion of patient's study participation. From Screening to Day 186. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Coversin Treatment. Ablation Dose: Day 1. 60 mg and 30 mg (12 Hours Apart) | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Coversin Treatment. Initiation Dose: Days 2 - 28. 22.5 mg Twice a Day (12 Hours Apart) | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) |
| Coversin Treatment. Maintenance Dose: Days 29 - 180. 45 mg Once Daily | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Event | Coversin Treatment. Ablation Dose: Day 1. 60 mg and 30 mg (12 Hours Apart) | Coversin Treatment. Initiation Dose: Days 2 - 28. 22.5 mg Twice a Day (12 Hours Apart) | Coversin Treatment. Maintenance Dose: Days 29 - 180. 45 mg Once Daily |
|---|---|---|---|
| Device related InfectionInfections and infestations | 0/1 | 1/1 | 0/1 |
| Febrile NeutropeniaBlood and lymphatic system disorders | 0/1 | 1/1 | 0/1 |
| Urinary Tract InfectionInfections and infestations | 0/1 | 1/1 | 0/1 |
| Event | Coversin Treatment. Ablation Dose: Day 1. 60 mg and 30 mg (12 Hours Apart) | Coversin Treatment. Initiation Dose: Days 2 - 28. 22.5 mg Twice a Day (12 Hours Apart) | Coversin Treatment. Maintenance Dose: Days 29 - 180. 45 mg Once Daily |
|---|---|---|---|
| Aspartate Aminotransferase IncreasedInvestigations | 0/1 | 1/1 | 0/1 |
| Hot FlushVascular disorders | 0/1 | 1/1 | 0/1 |
| NauseaGastrointestinal disorders | 0/1 | 1/1 | 0/1 |
| Urinary Tract InfectionInfections and infestations | 0/1 | 1/1 | 0/1 |
| VomitingGastrointestinal disorders | 0/1 | 1/1 | 0/1 |
| HypoglycaemiaMetabolism and nutrition disorders | 0/1 | 1/1 | 0/1 |
| HeadacheNervous system disorders | 0/1 | 1/1 | 0/1 |
| Age, Categorical(Participants) | Coversin Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Coversin Treatment |
|---|---|
| Female | 1 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Coversin Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Height(cm) | Coversin Treatment |
|---|---|
| Number | 155 |
| Weight(kg) | Coversin Treatment |
|---|---|
| Number | 73.3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2018 to primary completion in Nov 2018, 6 months.
Results were first posted in May 2025, 6 years 5 months after primary completion.
Of 26 industry-sponsored phase 2 interventional studies under Hemoglobinuria, Paroxysmal, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 25. This study's 6 months is below that.
Counting every sponsor, half of 34 studies reached it within 24 months; a quarter within 12 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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AKARI Therapeutics