Paroxysmal Nocturnal Hemoglobinuria (PNH)Phase 2CONSENTIINCT03427060
Coversin in PNH in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms
A Phase 2 study testing Coversin in people with Paroxysmal Nocturnal Hemoglobinuria (PNH), run by AKARI Therapeutics at 1 site in United States.
Trial summary
Coversin in Paroxysmal Nocturnal Hemoglobinuria (PNH) in patients with resistance to Eculizumab due to complement C5 polymorphisms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Nocturnal Hemoglobinuria (PNH)
- What is being tested?
- Coversin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2018to 3 Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with known PNH.
- Aged 18 and above. No upper age limit.
- Lactate dehydrogenase (LDH) ≥1.5 upper limit of normal.
- Must agree to use two methods of contraception that are ≥99% effective in preventing pregnancy.
- Resistance to eculizumab (Soliris®).
- Voluntary written informed consent.
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- Willing to self-inject Coversin daily.
- Willing to receive appropriate prophylaxis against Neisseria infection.
- Willing to avoid prohibited medications for duration of study.
Who cannot join
- Subjects with body weight <50 kg (110 lb) or >100 kg (220 lb).
- Pregnancy or breast feeding (females).
- Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom).
- Unresolved Neisseria meningitidis infection.
- Patients who have not received adequate immunization against Neisseria meningitides.
- Impaired hepatic function.
- Patients with impaired renal function.
- Failure to satisfy the Principal Investigator (PI) of fitness to participate for any other reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: CONSENT II: Coversin in Paroxysmal Nocturnal Hemoglobinuria (PNH) in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms
Coversin in Paroxysmal Nocturnal Hemoglobinuria (PNH) in patients with resistance to Eculizumab due to complement C5 polymorphisms.
Read the detailed description
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.
- Being tested
- Coversin
- Medical subject headings
- Hemoglobinuria, Paroxysmal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoversinDrug
Coversin - 22.5mg followed by 45mg for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Coversin treatment | Experimental | Coversin - 22.5mg followed by 45mg for 6 months. Receives: Drug: Coversin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Serum Lactate Dehydrogenase (LDH)
Measurement of serum lactate dehydrogenase (LDH)
Measured: Baseline to Day 186
Secondary outcomes (2)
Percentage Change in Haemoglobin (Hb) Compared to Screening
Percentage change in the haemoglobin (Hb) value at each study visit compared to screening
Measured: Baseline to Day 186
Number of Packed Red Blood Cells (PRBC) Transfusions
Number of units of packed red blood cells (PRBC) transfusions
Measured: Baseline to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start14 May 2018
- Primary completion15 Nov 2018
- Study completion3 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Paroxysmal Nocturnal Hemoglobinuria (PNH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- AKARI Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427060
- Sponsor's protocol ID
- AK585
- Acronym
- CONSENTII
- Status last verified
- Dec 2024
- First submitted
- 24 Jan 2018
- Last updated
- 4 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONSENT II: Coversin in Paroxysmal Nocturnal Hemoglobinuria (PNH) in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms
- ClinicalTrials.gov ID
- NCT03427060
- Acronym / sponsor ID
- CONSENTII / AK585
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- AKARI TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 14 May 2018 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 3 Feb 2021 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Posted 4 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coversin in Paroxysmal Nocturnal Hemoglobinuria (PNH) in patients with resistance to Eculizumab due to complement C5 polymorphisms.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coversin treatment | Experimental | Drug: CoversinCoversin - 22.5mg followed by 45mg for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with known PNH.
- Aged 18 and above. No upper age limit.
- Lactate dehydrogenase (LDH) ≥1.5 upper limit of normal.
- Must agree to use two methods of contraception that are ≥99% effective in preventing pregnancy.
- Resistance to eculizumab (Soliris®).
Key exclusion criteria (8 listed)
- Subjects with body weight <50 kg (110 lb) or >100 kg (220 lb).
- Pregnancy or breast feeding (females).
- Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom).
- Unresolved Neisseria meningitidis infection.
- Patients who have not received adequate immunization against Neisseria meningitides.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoversinCoversin - 22.5mg followed by 45mg for 6 months. | Drug | Coversin treatment |
Primary outcome
Measurement of Serum Lactate Dehydrogenase (LDH)
Time frame: Baseline to Day 186
Measurement of serum lactate dehydrogenase (LDH)
2 secondary outcomes
Percentage Change in Haemoglobin (Hb) Compared to Screening
Time frame: Baseline to Day 186
Number of Packed Red Blood Cells (PRBC) Transfusions
Time frame: Baseline to Day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Study of Efficacy and Safety of FXS6837 in Anti-C5 Treated PNH Patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Coversin in people with Paroxysmal Nocturnal Hemoglobinuria (PNH), run by AKARI Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Serum Lactate Dehydrogenase (LDH) (time frame: Baseline to Day 186). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.