Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIPD

• Register: EUCTR
• Last refreshed on: 6 February 2017
• Main ID: EUCTR2016-000374-37-FR
• Date of registration: 23/11/2016
• Prospective Registration: No
• Primary sponsor: Baxalta Innovations GmbH
• Public title: Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIPD
• Scientific title: Long-Term Tolerability and Safety of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
• Date of first enrolment: 28/10/2016
• Target sample size: 149
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000374-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Canada, Colombia, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Mexico, Norway, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom

Contacts

• Name: Andras Nagy
• Affiliation: Baxalta Innovation GmbH

• Name: Andras Nagy
• Affiliation: Baxalta Innovation GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
Has completed Epoch 1 of Study 161403 or Study 161601 without CIDP worsening.
If female of childbearing potential, the subject must have a negative pregnancy test at baseline and agree to employ adequate birth control measures (e.g. birth control pills/patches,intrauterine device (IUD), or diaphragm or condom [for male partner] with spermicidal jelly or foam) throughout the course of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 134
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion criteria:
Subject has a serious medical condition such that in the opinion of the investigator the subject’s safety or medical care would be impacted by participation in this Extension Study.
New medical condition that developed during participation in Study 161403 or Study 161601 that in the judgment of the investigator could increase risk to the subject or interfere with the evaluation of investigational medicinal product and/or conduct of the study.
Subject is scheduled to participate in another, non-Baxalta clinical study involving an IP or investigational device during the course of this study.
The subject is nursing or intends to begin nursing during the course of the study.
Subject has participated in another clinical study involving an IP or investigational device within 30 days prior to enrollment, or is scheduled to participate in another clinical study (with the exception of Study 161403 or 161601) involving an IP or investigational device during the course of this study.
The subject is a family member or employee of the investigator.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic inflammatory demyelinating polyradiculoneuropathy
MedDRA version: 19.0 Level: PT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: HyQvia 100 mg/ml solution for infusion for subcutaneous use
Product Name: HyQvia
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): Safety/Tolerability
Number (percentage) of subjects experiencing any treatment-emergent serious and/or non-serious adverse events (SAEs and/or AEs, respectively), regardless of causality
Number (percentage) of subjects experiencing causally related SAEs and/or AEs
Number (percentage) of subjects with serious and/or non-serious adverse reactions (ARs) plus suspected ARs
Rate of AEs that may be a result of immune-mediated response to either immunoglobulin,rHuPH20, or other factors as listed in Table 12-1, expressed as number of events per infusion and per subject-year
Number (percentage) of infusions associated with treatment-emergent SAEs and/or AEs, regardless of causality
Number (percentage) of infusions associated with causally related SAEs and/or AEs
Number (percentage) of infusions temporally associated with AEs (defined as AEs
occurring during or within 72 hours after completion of an infusion)
Number (percentage) of infusions associated with serious and/or non-serious ARs plus suspected ARs
Number (percentage) of infusions associated with 1 or more systemic AEs
Number (percentage) of infusions associated with 1 or more local infusion site reactions
Number and proportion of infusions for which the infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or AEs
Rates of systemic and local AEs, regardless of causality, expressed as number of events per infusion, per subject, and per subject-year
Rates of causally related systemic and local AEs, expressed as number of events per infusion, per subject, and per subject-year
Rates of systemic and local ARs plus suspected ARs, expressed as number of events per infusion, per subject, and per subject-year
Number of subjects with AE(s) that led to discontinuation from study
Number and rate per infusion of moderate or severe AEs that may be a result of immune mediated response to either immunoglobulin, rHuPH20 or other factors
Immunogenicity
Incidence of binding antibodies to rHuPH20
Incidence of neutralizing antibodies to rHuPH20
Number of subjects with a decline of anti-rHuPH20 antibody titers to the antibody titer level at baseline in study 161403 or 161601 and/or to <160 at the study completion or early discontinuation
For subjects who have >10,000 titer of binding antibodies to rHuPH20:
neutralizing antibodies and cross reactivity with Hyal-1,2 and 4

Secondary Objective: To assess the long-term effect of HYQVIA/HyQvia on clinical outcome measures, including prevention of relapse, change in functional ability, hand grip strength, and muscle strength.
To assess the long-term effect of HYQVIA/HyQvia on quality of life, health utility, health resource utilization (HRU), treatment satisfaction, treatment preference, and subject global impression of change.
To explore further the pharmacokinetics of HYQVIA/HyQvia in CIDP subjects.

Main Objective: To evaluate the long-term safety, tolerability, and immunogenicity of HYQVIA/HyQvia.

Timepoint(s) of evaluation of this end point: Week 96

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Pharmacokinetics
Timepoints: Week 1, 2, 13, 26, 39, 52, 65, 78, 91, 104
Efficacy measures
Timepoints: Week 13, 26, 39, 52, 65, 78, 91, 104
EuroQoL
Timepoints: Baseline, week 26, 52, 78
HRU
Timepoints: Baseline, Week 13, 26, 39, 52, 65,78, 91, 104
Treatment satisfaction
Timepoints: Baseline, week 26, 52, 78
Treatment preference
Timepoints: Baseline, week 26, 52, 78
Administration outcomes
Timepoints: Every 2, 3, or 4 weeks (every infusion)

Secondary end point(s): Outcome measures
Pharmacokinetics—Serum IgG levels
Efficacy measures
Proportion subjects who relapse
EuroQoL
HRU
Treatment satisfaction
Treatment preference
Administration outcomes
Number of sites per infusion
Maximum volume per infusion site
Time to administer the study product (immunoglobulin/rHuPH20)
Monthly infusion time
Number of subjects/caregivers unable to continue with self/home infusion and reason(s) for this failure.
Maximum infusion rates
Optional photo recording of infusion procedures

Secondary ID(s)

161505

Source(s) of Monetary Support

Baxalta Innovations GmbH