A Phase 4 interventional study of C1-esterase inhibitor [recombinant] (C1-INH-R) in CVI - Common Variable Immunodeficiency, sponsored by IMMUNOe Research Centers. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-15.
Sponsored by IMMUNOe Research Centers · Phase 4, Interventional, and Prevention
Patients receiving intravenous immunoglobulin (IVIG) therapy for primary immunodeficiency and neurologic conditions may experience adverse drug reactions (ADRs). The mechanism of the ADR is unknown. Currently, the standard practice for these patients is to change from IV to subcutaneous IG (SCIG) but because of the need of immunomodulation or patient preference, SCIG may not be an option. Data has shown that some levels of complement decrease from pre- to post-infusion of IVIG. This study is to determine if replacing this complement protein may ameliorate ADRs.
This is a single-site, pilot study conducted in the US to determine the benefit of human C1-esterase inhibitor [recombinant] (C1-INH-R) therapy to ameliorate ADRs in subjects receiving IVIG therapy experience ADRs post-infusion. Subjects who are currently receiving IVIG for immunodeficiency or neurologic conditions and experience ADRs will be enrolled.
In part 1, subjects will continue to receive IVIG for two infusions. Complement proteins will be measured pre- and post-infusion. Quality of life and other questionnaires will be administered.
In part 2, subjects will receive C1-INH-R infusion prior to receiving IVIG infusion for three infusions. Complement proteins will be measured pre- and post- infusion. Quality of life and other questionnaires will be administered.
54 studies on the registry are indexed under Common Variable Immunodeficiency; 13 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 39 interventional studies indexed under Common Variable Immunodeficiency.
Browse Common Variable Immunodeficiency studies →IMMUNOe Research Centers is the lead sponsor of 4 studies on the registry; none are open to participants now.
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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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Single-site, open-label arm to evaluate the benefit of C1-INH-R in subjects on IVIG therapy who experience ADRs. The study will have 2 periods: * 6 - 8 weeks - subjects will receive 2 infusions of IVIG * 9 - 12 weeks - subjects will receive 3 infusions of C1-INH-R prior to IVIG infusion
Biological: C1-esterase inhibitor [recombinant] (C1-INH-R)
C1-INH-R is FDA approved and indicated for the treatment of acute attacks of angioedema in adolescent and adult patients with Hereditary Angioedema (HAE) as a replacement for low levels of C1-esterase inhibitor or low function of C1-esterase inhibitor
The change in Modified Fatigue Severity Scale (mFSS)
Subject-rated Rasch-built 7-item modified fatigue survey scale. Scale rated 0 - 3 (3 = agree, 0 = less agree)
Time frame: Measurement prior to infusion 3 (week 9 - 12) compared to end of study (week 19 - 25)
The change in Modified Fatigue Impact Scale (MFIS)
Subject-rated 24 item questionnaire measuring the impact of fatigue rated 0 - 4 (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = almost always)
Time frame: Measurement prior to infusion 3 (week 9 - 12) compared to end of study (week 19 - 25)
The change in Migraine Disability Assessment (MIDAS)
Headache severity measurement of number of days affected after infusion
Time frame: Measurement prior to infusion 3 (week 9 - 12) compared to end of study (week 19 - 25)
The change in Headache Impact Scale (HIT-6)
Subject-rated measurement of the impact headaches have on the ability to function on the job, at school, at home and in social situations. 6 item questionnaire rated from never (6 points each), rarely (8 points each), sometimes (10 points each), very often (11 points each), always (13 points each). The higher number the more the impact.
Time frame: Measurement prior to infusion 3 (week 9 - 12) compared to end of study (week 19 - 25)
The change in Activities of Daily Living Sliding Scale
Subject-rated 10 point scale measuring level of activity with 1 being the worst (least) and 10 being the best (greatest)
Time frame: Measurement prior to infusion 3 (week 9 - 12) compared to end of study (week 19 - 25)
The change in Activities of Daily Living Questionnaire
Calculates the number of days missed from work, school/daycare/activities, housework, and regular exercise
Time frame: Measurement prior to infusion 3 (week 9 - 12) compared to end of study (week 19 - 25)
The change in Energy Sliding Scale
Subject-rated10 point scale measuring energy level with 1 being the worst (Lowest) and 10 being the best (highest)
Time frame: Measurement prior to infusion 3 (week 9 - 12) compared to end of study (week 19 - 25)
The change in Infection Questionnaire
Subject-rated 7 item infection questionnaire measured from 1 to 10 with 1 being the least affected and 10 being the most affected.
Time frame: Measurement prior to infusion 3 (week 9 - 12) compared to end of study (week 19 - 25)
The change in Perceived Deficits Questionnaire - cognitive assessment
Subject-rated 20 item questionnaire measuring memory, attention and concentration rated 0 to 4 (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = almost always) with the lower score being least impact.
Time frame: Measurement prior to infusion 3 (week 9 - 12) compared to end of study (week 19 - 25)
The change in 36 item short form survey (SF-36)
Health Survey asks 36 questions to measure functional health and well-being from the patient's point of view.
Time frame: Measurement prior to infusion 3 (week 9 - 12) compared to end of study (week 19 - 25)
Change in the number of ADRs
Adverse reactions to infusions
Time frame: Measured at each infusion (every 3 - 4 weeks)
Change in levels of C1-INH pre- and post-infusion
Laboratory levels of C1-INH total and functional
Time frame: Measurement at each infusion (every 3 - 4 weeks)
Plan to share: No
Ran from Jun 2018 to primary completion in Dec 2019, 17 months.
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Complement C1 Inhibitor Protein
Common Variable Immunodeficiency →
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