Trial · NCT02549170

A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

NCT02549170, Phase 3, Completed, Baxalta now part of Shire; results first posted 2023-05-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). Trials, record NCT02549170. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02549170

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
NCT number: NCT02549170
Status: Completed
Phases: Phase 3
Enrollment: 138 participants, actual
Lead sponsor: Baxalta now part of Shire
Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Interventions: HYQVIA, 0.25% albumin placebo solution with rHuPH20, IGIV GAMMAGARD LIQUID/KIOVIG, IGIV GAMUNEX®-C
First posted: 2015-09-15
Last updated: 2023-05-24
Other registries' IDs: eudract:2014-005496-87
Results first posted: 2023-05-24

Source ClinicalTrials.gov

Registered outcomes45

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Epoch 1: Relapse Rate	Week 32 End of Epoch 1 Treatment (EOET1)/Unscheduled relapse visit assessment (UV)/Early Termination (ET)	Relapse rate is defined as the percentage of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of \>=1 point relative to the pre- subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
Primary	Epoch 2: Responder Rate	Up to 6 Months post-Epoch 1 (End of Epoch 2 Treatment [EOE2T])/Unscheduled visit assessment (UV)/Early Termination	Responder rate is defined as clinically meaningful improvement in functional ability defined as a decrease of \>=1 point in the adjusted INCAT disability score at the completion of the intravenous (IV) treatment period \[6 months\] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score.
Secondary	Epoch 1: Percentage of Participants Who Experience a Worsening of Functional Disability	Week 32 (EOET1)/UV/ET	Defined as one or more of the following: an increase of \>=1 point relative to the pre-subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) scores; who experience CIDP worsening (defined as a \>=8 kilo Pascal (kPa) decrease in the hand grip strength in the more affected hand); \>=4 points decrease in raw Rasch-built Overall Disability Scale (R-ODS) relative to the pre-SC treatment baseline score (at the time of withdrawal from the SC treatment period). Participants are rounded off to nearest single decimal point.
Secondary	Time to Relapse	Week 32 (EOET1)/UV/ET	Time to relapse is defined as time from the date of the first SC administration of HYQVIA/HyQvia or placebo with rHuPH20 to the date of relapse. Participants who did not relapse were censored at their end of study.
Secondary	Epoch 1: Change From Pre-Subcutaneous (SC) Treatment Baseline in Rasch-built Overall Disability Scale (R-ODS)	Pre-subcutaneous (SC) treatment baseline, end of Epoch 1 treatment (approximately 7.3 months)	The Rasch-Built Overall Disability Scale (R-ODS) is a participant self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in participant with immune-mediated peripheral neuropathies including CIDP. The R-ODS is comprised of 24 items for which participants are asked to rate their functioning (i.e, no difficulty, some difficulty, or could not do) related to a variety of everyday tasks at the moment of completion. The centile metric R-ODS score range is 0 to 100. Higher scores indicate better condition. The centile metric R-ODS score was used in the ANCOVA analysis. ANCOVA was used for the analysis.
Secondary	Epoch 1: Number of Participants Experiencing Any Treatment-Emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs), Regardless of Causality	Week 32 (EOET1)/UV/ET	An AE is defined as any untoward medical occurrence in participant administered an Investigational Product (IP) that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.
Secondary	Epoch 1: Number of Participants Experiencing Causally Related Serious and/or Non-Serious Adverse Events (SAEs and/or AEs)	Week 32 (EOET1)/UV/ET	AE=any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g.,abnormal laboratory finding), symptom (e.g.,rash, pain, discomfort, fever, dizziness, etc.), disease (e.g.,peritonitis,bacteremia,etc.), outcome of death temporally associated with use of IP,considered causally related to the IP. SAE=untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, thromboembolic events, hemolytic anemia. Non-SAE=AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.
Secondary	Epoch 1: Number of Participants With Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs	Week 32 (EOET1)/UV/ET	An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.
Secondary	Epoch 1: Number of Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions Regardless of Causality	Week 32 (EOET1)/UV/ET	AE: any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. SAE: an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. Participants can have more than one adverse event.
Secondary	Epoch 1: Number of Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions	Week 32 (EOET1)/UV/ET	AE: any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), outcome of death temporally associated with use of IP, whether or not considered causally related to the IP. SAE: untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, (e.g., thromboembolic events, hemolytic anemia). Non-SAE:AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.

1 to 10 of 45Source ClinicalTrials.gov

See all 45 registered outcomes

Outcomes45

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Epoch 1: Relapse Rate	Week 32 End of Epoch 1 Treatment (EOET1)/Unscheduled relapse visit assessment (UV)/Early Termination (ET)	MITT analysis set included all randomized participants who received any double-blind study medication.	percentage of participants	NUMBER
PRIMARY	Epoch 2: Responder Rate	Up to 6 Months post-Epoch 1 (End of Epoch 2 Treatment [EOE2T])/Unscheduled visit assessment (UV)/Early Termination	E1:Placebo Relapse / E2:GGL/KIOVIG Set included a subset of participants who had a relapse while on placebo in Epoch 1, entered Epoch 2, and were treated with GAMMAGARD LIQUID/KIOVIG in Epoch 2.	percentage of participants	NUMBER
SECONDARY	Epoch 1: Percentage of Participants Who Experience a Worsening of Functional Disability	Week 32 (EOET1)/UV/ET	MITT analysis set included all randomized participants who received any double-blind study medication. Overall number of participants analyzed is the number of participants available with data.	percentage of participants	NUMBER
SECONDARY	Time to Relapse	Week 32 (EOET1)/UV/ET	MITT analysis set included all randomized participants who received any double-blind study medication.	days	MEDIAN
SECONDARY	Epoch 1: Change From Pre-Subcutaneous (SC) Treatment Baseline in Rasch-built Overall Disability Scale (R-ODS)	Pre-subcutaneous (SC) treatment baseline, end of Epoch 1 treatment (approximately 7.3 months)	MITT analysis set included all randomized participants who received any double-blind study medication. Overall number of participants analyzed is the number of participants available with data.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Epoch 1: Number of Participants Experiencing Any Treatment-Emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs), Regardless of Causality	Week 32 (EOET1)/UV/ET	Epoch 1 safety analysis set included all participants who received any study treatment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Epoch 1: Number of Participants Experiencing Causally Related Serious and/or Non-Serious Adverse Events (SAEs and/or AEs)	Week 32 (EOET1)/UV/ET	Epoch 1 safety analysis set included all participants who received any study treatment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Epoch 1: Number of Participants With Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs	Week 32 (EOET1)/UV/ET	Epoch 1 safety analysis set included all participants who received any study treatment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Epoch 1: Number of Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions Regardless of Causality	Week 32 (EOET1)/UV/ET	Epoch 1 safety analysis set included all participants who received any study treatment. Participants can have more than one adverse event.	events in participants	NUMBER
SECONDARY	Epoch 1: Number of Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions	Week 32 (EOET1)/UV/ET	Epoch 1 safety analysis set included all participants who received any study treatment. Participants can have more than one causally related adverse event.	causally related events in participants	NUMBER

1 to 10 of 45Source ClinicalTrials.gov

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Results by group182

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Epoch 1: Relapse Rate	Epoch 1: Placebo With rHuPH20		31.4	95% Confidence Interval 21.76 to 43.03	percentage of participants
Epoch 1: Relapse Rate	Epoch 1: HYQVIA/HyQvia		9.7	95% Confidence Interval 4.51 to 19.55	percentage of participants
Epoch 2: Responder Rate	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG		100	95% Confidence Interval 80.64 to 100.00	percentage of participants
Epoch 1: Percentage of Participants Who Experience a Worsening of Functional Disability	Epoch 1: Placebo With rHuPH20		54.4	95% Confidence Interval 42.66 to 65.70	percentage of participants
Epoch 1: Percentage of Participants Who Experience a Worsening of Functional Disability	Epoch 1: HYQVIA/HyQvia		37.5	95% Confidence Interval 26.01 to 50.59	percentage of participants
Time to Relapse	Epoch 1: Placebo With rHuPH20		NA	Full Range 20 to 221	days
Time to Relapse	Epoch 1: HYQVIA/HyQvia		NA	Full Range 7 to 217	days
Epoch 1: Change From Pre-Subcutaneous (SC) Treatment Baseline in Rasch-built Overall Disability Scale (R-ODS)	Epoch 1: Placebo With rHuPH20		-6.1	Standard Error 1.64	score on a scale
Epoch 1: Change From Pre-Subcutaneous (SC) Treatment Baseline in Rasch-built Overall Disability Scale (R-ODS)	Epoch 1: HYQVIA/HyQvia		-0.9	Standard Error 1.69	score on a scale
Epoch 1: Number of Participants Experiencing Any Treatment-Emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs), Regardless of Causality	Epoch 1: Placebo With rHuPH20	Any TEAE	40		Participants

1 to 10 of 182Source ClinicalTrials.gov

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Participant flow30

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Epoch 1: Day 1 to Approximately 32 Weeks	STARTED	Epoch 1: Placebo With rHuPH20	70
Epoch 1: Day 1 to Approximately 32 Weeks	STARTED	Epoch 1: HYQVIA/HyQvia	62
Epoch 1: Day 1 to Approximately 32 Weeks	STARTED	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG	0
Epoch 1: Day 1 to Approximately 32 Weeks	STARTED	Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG	0
Epoch 1: Day 1 to Approximately 32 Weeks	STARTED	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C	0
Epoch 1: Day 1 to Approximately 32 Weeks	COMPLETED	Epoch 1: Placebo With rHuPH20	46
Epoch 1: Day 1 to Approximately 32 Weeks	COMPLETED	Epoch 1: HYQVIA/HyQvia	48
Epoch 1: Day 1 to Approximately 32 Weeks	COMPLETED	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG	0
Epoch 1: Day 1 to Approximately 32 Weeks	COMPLETED	Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG	0
Epoch 1: Day 1 to Approximately 32 Weeks	COMPLETED	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C	0

1 to 10 of 30Source ClinicalTrials.gov

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Adverse events190

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain upper	Gastrointestinal disorders	Epoch 1: Placebo With rHuPH20	0	70
other	Abdominal pain upper	Gastrointestinal disorders	Epoch 1: HYQVIA/HyQvia	0	62
other	Abdominal pain upper	Gastrointestinal disorders	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG	0	16
other	Abdominal pain upper	Gastrointestinal disorders	Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG	1	4
other	Abdominal pain upper	Gastrointestinal disorders	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C	0	1
other	Anaemia	Blood and lymphatic system disorders	Epoch 1: Placebo With rHuPH20	1	70
other	Anaemia	Blood and lymphatic system disorders	Epoch 1: HYQVIA/HyQvia	0	62
other	Anaemia	Blood and lymphatic system disorders	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG	1	16
other	Anaemia	Blood and lymphatic system disorders	Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG	0	4
other	Anaemia	Blood and lymphatic system disorders	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C	0	1

1 to 10 of 190Source ClinicalTrials.gov

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Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Epoch 1: Placebo With rHuPH20	0	70
Total, all-cause mortality	Epoch 1: HYQVIA/HyQvia	0	62
Total, all-cause mortality	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG	0	16
Total, all-cause mortality	Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG	0	4
Total, all-cause mortality	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C	0	1
Total, other adverse events	Epoch 1: Placebo With rHuPH20	19	70
Total, other adverse events	Epoch 1: HYQVIA/HyQvia	42	62
Total, other adverse events	Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG	11	16
Total, other adverse events	Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG	3	4
Total, other adverse events	Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C	1	1

1 to 10 of 15Source ClinicalTrials.gov

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Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
42578463	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Epoch 1: Placebo With rHuPH20 vs Epoch 1: HYQVIA/HyQvia: Epoch 1: Number of Participants Who Develop Binding and/or Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02549170

GET https://conductscience.org/api/trials/v1/NCT02549170/registered?page=2

API reference For AI assistants