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rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study (CONSERVE)

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ClinicalTrials.gov Identifier: NCT03829449
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
AKARI Therapeutics

Brief Summary:
Patients with diseases requiring complement inhibition who have previously taken part in Akari clinical trials and who wish to continue to receive rVA576 (Coversin) after their active participation in the previous trial has completed and patients treated under compassionate use or named patient arrangements who wish to continue on rVA576 (Coversin) therapy.

Condition or disease Intervention/treatment Phase
Paroxysmal Nocturnal Hemoglobinuria Atypical Hemolytic Uremic Syndrome Drug: rVA576 (Coversin) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label, non-comparative
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study
Actual Study Start Date : March 13, 2017
Estimated Primary Completion Date : June 15, 2025
Estimated Study Completion Date : June 15, 2025


Arm Intervention/treatment
Experimental: rVA576 Coversin
The study population will consist of patients who have completed participation in clinical trials under other Akari protocols and who wish to continue to receive rVA576 (Coversin) for up to 4 years.
Drug: rVA576 (Coversin)
The study population will consist of patients who have completed participation in clinical trials under other Akari protocols and who wish to continue to receive rVA576 (Coversin).




Primary Outcome Measures :
  1. Long term safety and efficacy of rVA576 (Coversin) therapy assessed by AEs, SAEs, Standard Lab tests and ECG results. [ Time Frame: 4 years ]
    To determine the safety profile of long-term rVA576 (Coversin) treatment as assessed by AEs, SAEs, Standard Lab tests and ECG results.


Secondary Outcome Measures :
  1. Proportion of subjects with thrombotic and haemolytic event free status during each 3month time period since the start of the study. [ Time Frame: 12 weeks ]
    Proportion of subjects with thrombotic and haemolytic event free status during each 3month time period since the start of the study.

  2. Time to thrombotic or haemolytic event since joining this study. [ Time Frame: 4 years ]
    Time to thrombotic or haemolytic event since joining this study.

  3. Proportion of subjects who require PRBC transfusion during each 3-month period since the start of the study and over the entire period of the study [ Time Frame: 4 years ]
    Proportion of subjects who require PRBC transfusion during each 3-month period since the start of the study and over the entire period of the study

  4. Time to first transfusion since joining the study. [ Time Frame: 4 years ]
    Time to first transfusion since joining the study.

  5. Proportion of subjects with no adverse change in overall scores of Quality of Life using the EORTC QLQ-C30, the EQ-5D-5L and FACIT-F instruments at each 3-month time period since the start of the study. [ Time Frame: 12 weeks ]
    Proportion of subjects with no adverse change in overall scores of Quality of Life using the EORTC QLQ-C30, the EQ-5D-5L and FACIT-F instruments at each 3-month time period since the start of the study.

  6. Proportion of subjects with serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 times the upper limit of normal (ULN) at each 3-month time period since the start of the study. [ Time Frame: 12 weeks ]
    Proportion of subjects with serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 times the upper limit of normal (ULN) at each 3-month time period since the start of the study.

  7. Proportion of subjects with median serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 times the upper limit of normal (ULN) over the entire duration of the study. [ Time Frame: 4 years ]
    Proportion of subjects with median serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 times the upper limit of normal (ULN) over the entire duration of the study.

  8. Proportion of transfusion-independent subjects at each 3-month time point, with haemoglobin (g/L) above the baseline haemoglobin value they had at the start of the trial from which they entered CONSERVE [ Time Frame: 3 monthly ]
    Proportion of transfusion-independent subjects at each 3-month time point, with haemoglobin (g/L) above the baseline haemoglobin value they had at the start of the trial from which they entered CONSERVE

  9. Proportion of transfusion-independent subjects over the entire duration of the study with mean haemoglobin (g/L) above the baseline haemoglobin value they had at the start of the trial from which they entered CONSERVE [ Time Frame: 12 weeks ]
    Proportion of transfusion-independent subjects over the entire duration of the study with mean haemoglobin (g/L) above the baseline haemoglobin value they had at the start of the trial from which they entered CONSERVE

  10. Proportion of patients experiencing Major Adverse Vascular Events (MAVE) over the entire period of the study. [ Time Frame: 4 years ]
    Proportion of patients experiencing Major Adverse Vascular Events (MAVE) over the entire period of the study.

  11. Time to first Major Adverse Vascular Event (MAVE) for each subject since joining the study. [ Time Frame: 4 years ]
    Time to first Major Adverse Vascular Event (MAVE) for each subject since joining the study.

  12. Number of Major Adverse Vascular Events (MAVE) over the entire period of the study. [ Time Frame: 4 years ]
    Number of Major Adverse Vascular Events (MAVE) over the entire period of the study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 18 years and above treated with rVA576 (Coversin) under other Akari clinical trial protocols and wish to remain on rVA576 (Coversin) at the conclusion of that trial.
  2. In the opinion of the treating responsible clinician patient is receiving clinical benefit from continued treatment with study drug.
  3. Evidence of sustained complement inhibition by CH50 assay. .
  4. Women of childbearing potential (WOCBP) must agree to use effective contraception consistently throughout the study and have a negative pregnancy test at screening and a negative urine pregnancy test per the schedule of visits. Women cannot donate their eggs. Women are considered post-menopausal and not of childbearing potential if they have had 12 months of amenorrhea or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks previously.
  5. Males with a childbearing potential partner must agree to use effective contraception consistently OR have had a vasectomy
  6. Weight ≥50-100kg
  7. Willing to receive appropriate prophylaxis against Neisseria meningitidis infection, by both immunisation and continuous or intermittent antibiotics
  8. The patient is willing to give voluntary written informed consent
  9. The patient is willing in the process of preparation and self-administration of the study drug.

Exclusion Criteria:

  1. Patient experienced any safety event in the previous study protocol, which puts the patient at unacceptable risk in current protocol as judged by the investigator and sponsor.
  2. Patient is unwilling to complete the Quality of Life instruments and diary card
  3. Active meningococcal infection (section 4.3.1 for additional information)
  4. Any other reason for which, in the opinion of the Investigator, it would not be in the interests of the patient to remain on rVA576 (Coversin).
  5. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 90 days after last dose; or intending to donate ova during such time period.
  6. If male, the subject intends to donate sperm while on the study this study or for 90 days after last dose.
  7. Failure to satisfy the Investigator of fitness to participate for any other reason or any other condition which, in the opinion of the investigator, could increase the subject's risk by participating in the study or confound the outcome of the study.
  8. Use of prohibited medication
  9. The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse.
  10. Participation in other clinical trials with investigational product.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829449


Contacts
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Contact: Naresh Sabharwal 0208 004 6106 Naresh.Sabharwal@akaritx.com

Locations
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Poland
Instytut Hematologii i Transfuzjologii Recruiting
Warsaw, Poland, 02-776
Sponsors and Collaborators
AKARI Therapeutics

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Responsible Party: AKARI Therapeutics
ClinicalTrials.gov Identifier: NCT03829449     History of Changes
Other Study ID Numbers: AK581
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemoglobinuria
Hemolytic-Uremic Syndrome
Atypical Hemolytic Uremic Syndrome
Hemoglobinuria, Paroxysmal
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Anemia, Hemolytic
Anemia
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases
Uremia
Kidney Diseases
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders