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CUVITRUWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (0)


Name (Synonyms) Correlation

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D007153 Immunologic Deficiency Syndromes NIH 0.41

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002721 Immunodeficiency HPO 0.41

There is one clinical trial.

Clinical Trials


1 24-APR-2020: Real-world CANadian CUvitru Non-Interventional Study in Subjects Transitioning From Subcutaneous Immunoglobulin (CANCUN)

This study will provide insights on the infusion parameters, dosing, and experience of participants transitioning to CUVITRU in a real-world setting.

NCT03716700 Primary Immunodeficiency Diseases (PID) Biological: CUVITRU
MeSH:Immunologic Deficiency Syndromes
HPO:Immunodeficiency

Primary Outcomes

Description: Median infusion volume per site

Measure: Infusion parameter 1: Cohort 1-Start of data collection

Time: Baseline

Description: Median infusion volume per site

Measure: Infusion parameter 1: Cohort 1- Month 3

Time: Month 3

Description: Median infusion volume per site

Measure: Infusion parameter 1: Cohort 1- Month 6

Time: Month 6

Description: Median infusion volume per site

Measure: Infusion parameter 1: Cohort 1- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Median infusion volume per site

Measure: Infusion parameter 1: Cohort 2- Start of data collection

Time: Baseline

Description: Median infusion volume per site

Measure: Infusion parameter 1: Cohort 2- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Median infusion volume per infusion

Measure: Infusion parameter 1.1: Cohort 1- Start of data collection

Time: Baseline

Description: Median infusion volume per infusion

Measure: Infusion parameter 1.1: Cohort 1- Month 3

Time: Month 3

Description: Median infusion volume per infusion

Measure: Infusion parameter 1.1: Cohort 1- Month 6

Time: Month 6

Description: Median infusion volume per infusion

Measure: Infusion parameter 1.1: Cohort 1- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Median infusion volume per infusion

Measure: Infusion parameter 1.1: Cohort 2- Start of data collection

Time: Baseline

Description: Median infusion volume per infusion

Measure: Infusion parameter 1.1: Cohort 2- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Median number of infusion sites

Measure: Infusion parameter 2: Cohort 1- Start of data collection

Time: Baseline

Description: Median number of infusion sites

Measure: Infusion parameter 2: Cohort 1- Month 3

Time: Month 3

Description: Median number of infusion sites

Measure: Infusion parameter 2: Cohort 1- Month 6

Time: Month 6

Description: Median number of infusion sites

Measure: Infusion parameter 2: Cohort 1- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Median number of infusion sites

Measure: Infusion parameter 2: Cohort 2- Start of data collection

Time: Baseline

Description: Median number of infusion sites

Measure: Infusion parameter 2: Cohort 2- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Median infusion duration

Measure: Infusion parameter 3: Cohort 1- Start of data collection

Time: Baseline

Description: Median infusion duration

Measure: Infusion parameter 3: Cohort 1- Month 3

Time: Month 3

Description: Median infusion duration

Measure: Infusion parameter 3: Cohort 1- Month 6

Time: Month 6

Description: Median infusion duration

Measure: Infusion parameter 3: Cohort 1- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Median infusion duration

Measure: Infusion parameter 3: Cohort 2- Start of data collection

Time: Baseline

Description: Median infusion duration

Measure: Infusion parameter 3: Cohort 2- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Median number of infusions to reach participant's maximum infusion volume

Measure: Infusion parameter 3.1: Cohort 1- Month 3 Follow-up

Time: Month 3

Description: Median number of infusions to reach participant's maximum infusion volume

Measure: Infusion parameter 3.1: Cohort 1- Month 6 Follow-up

Time: Month 6

Description: Median number of infusions to reach participant's maximum infusion volume

Measure: Infusion parameter 3.1: Cohort 1- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Median number of infusions to reach participant's maximum infusion volume

Measure: Infusion parameter 3.1: Cohort 2- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Median number of infusions per month per participant

Measure: Infusion parameter 3.2: Cohort 1- Start of data collection

Time: Baseline

Description: Median number of infusions per month per participant

Measure: Infusion parameter 3.2: Cohort 1- Month 3

Time: Month 3

Description: Median number of infusions per month per participant

Measure: Infusion parameter 3.2: Cohort 1- Month 6

Time: Month 6

Description: Median number of infusions per month per participant

Measure: Infusion parameter 3.2: Cohort 1- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Median number of infusions per month per participant

Measure: Infusion parameter 3.2: Cohort 2- Start of data collection

Time: Baseline

Description: Median number of infusions per month per participant

Measure: Infusion parameter 3.2: Cohort 2- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Median number of infusions to reach final dose interval per participant

Measure: Infusion parameter 3.3: Cohort 1- Start of data collection

Time: Baseline

Description: Median number of infusions to reach final dose interval per participant

Measure: Infusion parameter 3.3: Cohort 1- Month 3

Time: Month 3

Description: Median number of infusions to reach final dose interval per participant

Measure: Infusion parameter 3.3: Cohort 1- Month 6

Time: Month 6

Description: Median number of infusions to reach final dose interval per participant

Measure: Infusion parameter 3.3: Cohort 1- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Median number of infusions to reach final dose interval per participant

Measure: Infusion parameter 3.3: Cohort 2- Start of data collection

Time: Baseline

Description: Median number of infusions to reach final dose interval per participant

Measure: Infusion parameter 3.3: Cohort 2- 12 Month final follow-up

Time: 12 Month final follow-up

Secondary Outcomes

Description: Median maximal infusion rate per site

Measure: Infusion parameter 4.1: Cohort 1- Start of data collection

Time: Baseline

Description: Median maximal infusion rate per site

Measure: Infusion parameter 4.1: Cohort 1- Month 3

Time: Month 3

Description: Median maximal infusion rate per site

Measure: Infusion parameter 4.1: Cohort 1- Month 6

Time: Month 6

Description: Median maximal infusion rate per site

Measure: Infusion parameter 4.1: Cohort 1- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Median maximal infusion rate per site

Measure: Infusion parameter 4.1: Cohort 2- Start of data collection

Time: Baseline

Description: Median maximal infusion rate per site

Measure: Infusion parameter 4.1: Cohort 2- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Number of infusions that are discontinued, slowed, or interrupted

Measure: Infusion parameter 4.2: Cohort 1- Start of data collection

Time: Baseline

Description: Number of infusions that are discontinued, slowed, or interrupted

Measure: Infusion parameter 4.2: Cohort 1- Month 3

Time: Month 3

Description: Number of infusions that are discontinued, slowed, or interrupted

Measure: Infusion parameter 4.2: Cohort 1- Month 6

Time: Month 6

Description: Number of infusions that are discontinued, slowed, or interrupted

Measure: Infusion parameter 4.2: Cohort 1- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Number of infusions that are discontinued, slowed, or interrupted

Measure: Infusion parameter 4.2: Cohort 2- Start of data collection

Time: Baseline

Description: Number of infusions that are discontinued, slowed, or interrupted

Measure: Infusion parameter 4.2: Cohort 2- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Median number of infusions to reach participant's maximum infusion rate

Measure: Infusion parameter 4.3: Cohort 1- Month 3

Time: Month 3

Description: Median number of infusions to reach participant's maximum infusion rate

Measure: Infusion parameter 4.3: Cohort 1- Month 6

Time: Month 6

Description: Median number of infusions to reach participant's maximum infusion rate

Measure: Infusion parameter 4.3: Cohort 1- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Median number of infusions to reach participant's maximum infusion rate

Measure: Infusion parameter 4.3: Cohort 2- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Mean dose

Measure: Infusion parameter 5.1: Cohort 1- Start of data collection

Time: Baseline

Description: Mean dose

Measure: Infusion parameter 5.1: Cohort 1- Month 3

Time: Month 3

Description: Mean dose

Measure: Infusion parameter 5.1: Cohort 1- Month 6

Time: Month 6

Description: Mean dose

Measure: Infusion parameter 5.1: Cohort 1- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Mean dose

Measure: Infusion parameter 5.1: Cohort 2- Start of data collection

Time: Baseline

Description: Mean dose

Measure: Infusion parameter 5.1: Cohort 2- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Mean dosing interval

Measure: Infusion parameter 5.2: Cohort 1- Start of data collection

Time: Baseline

Description: Mean dosing interval

Measure: Infusion parameter 5.2: Cohort 1- Month 3

Time: Month 3

Description: Mean dosing interval

Measure: Infusion parameter 5.2: Cohort 1- Month 6

Time: Month 6

Description: Mean dosing interval

Measure: Infusion parameter 5.2: Cohort 1- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Mean dosing interval

Measure: Infusion parameter 5.2: Cohort 2- Start of data collection

Time: Baseline

Description: Mean dosing interval

Measure: Infusion parameter 5.2: Cohort 2- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Mean number of dose adjustments

Measure: Infusion parameter 5.3: Cohort 1- Start of data collection

Time: Baseline

Description: Mean number of dose adjustments

Measure: Infusion parameter 5.3: Cohort 1- Month 3

Time: Month 3

Description: Mean number of dose adjustments

Measure: Infusion parameter 5.3: Cohort 1- Month 6

Time: Month 6

Description: Mean number of dose adjustments

Measure: Infusion parameter 5.3: Cohort 1- 12 Month final follow-up

Time: 12 Month final follow-up

Description: Mean number of dose adjustments

Measure: Infusion parameter 5.3: Cohort 2- Start of data collection

Time: Baseline

Description: Mean number of dose adjustments

Measure: Infusion parameter 5.3: Cohort 2- 12 Month final follow-up

Time: 12 Month final follow-up

Description: TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant's satisfaction with medication. The three domains assessed are effectiveness, convenience, and global satisfaction

Measure: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 1

Time: 12 Month final follow-up

Description: TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant's satisfaction with medication. The three domains assessed are effectiveness, convenience, and global satisfaction

Measure: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 2

Time: 12 Month final follow-up

Description: The LQI is a self-administered questionnaire developed specifically for participants/legal guardians involved in IVIG treatments. It consists of 15-items, divided into four domains: treatment interferences (6 items), therapy-related problems (4 items), therapy setting (3 items), and treatment costs (2 items). Items are rated on a 7-point Likert-type scale ranging from 1: "Extremely bad" to 7: "Extremely good". Total scores range from 15 to 105, with higher scores indicating the highest possible satisfaction with factors such as independence, therapy convenience, social/school/work activities, and health and travel costs

Measure: Life Quality Index (LSI): Cohort 1

Time: 12 Month final follow-up

Description: The LQI is a self-administered questionnaire developed specifically for participants/legal guardians involved in IVIG treatments. It consists of 15-items, divided into four domains: treatment interferences (6 items), therapy-related problems (4 items), therapy setting (3 items), and treatment costs (2 items). Items are rated on a 7-point Likert-type scale ranging from 1: "Extremely bad" to 7: "Extremely good". Total scores range from 15 to 105, with higher scores indicating the highest possible satisfaction with factors such as independence, therapy convenience, social/school/work activities, and health and travel costs

Measure: Life Quality Index (LSI): Cohort 2

Time: 12 Month final follow-up

Description: The TPQ is a self-administered questionnaire developed to assess participants' preference towards the administration of new subcutaneous immunoglobulin G (SCIG) therapy. There are 4-items on the questionnaire, which investigate a participant's preference on the clinic/hospital/home setting of receiving the immunoglobulin therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the SCIG treatment.

Measure: Treatment Preference Questionnaire: Cohort 1

Time: 12 Month final follow-up

Description: The TPQ is a self-administered questionnaire developed to assess participants' preference towards the administration of new subcutaneous immunoglobulin G (SCIG) therapy. There are 4-items on the questionnaire, which investigate a participant's preference on the clinic/hospital/home setting of receiving the immunoglobulin therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the SCIG treatment.

Measure: Treatment Preference Questionnaire: Cohort 2

Time: 12 Month final follow-up


Related HPO nodes (Using clinical trials)


HP:0002721: Immunodeficiency
Genes 268
PIK3CA CCDC47 CTBP1 ATRX NHEJ1 BLNK CHD1 CD81 NOP10 IKBKB CD79A TNFRSF13C CD19 AICDA LIG4 CD19 IRF2BP2 LAMTOR2 IFNGR1 UNC119 IGHM TTC7A CD81 PNP SPATA5 RAG2 PKP1 WRAP53 ADA2 TTC37 FGFRL1 CLCA4 TERT RAG1 HYOU1 LAT TYK2 LRBA TTC7A NFE2L2 CD19 DCTN4 RREB1 CD40LG FRAS1 IKBKG TNFRSF13B CFTR RAG1 IRAK4 MAN2B1 CTLA4 JAK3 SHANK3 AGL IL21 ICOS PRKDC TNFRSF13C XRCC4 LIG4 CARD9 BSCL2 TBCE CTPS1 IL7R ANTXR2 MAN2B1 HELLS IL21R MALT1 CD3G LAMTOR2 AP3D1 CD40 ARVCF MBTPS2 ACP5 PTPRC NFKB2 TFRC MS4A1 MAPK1 MTHFD1 LYST ADA POLE RAG2 XIAP SDHC DNMT3B UNG BCL11B DOCK2 ORAI1 RTEL1 IL12RB1 TLR3 FOS AK2 IL2RG TRAF3 CTLA4 DCLRE1C SIN3A SLC46A1 LRRC8A AGPAT2 TINF2 DCLRE1C IRF7 GP1BB TGFB1 UFD1 PPARG LETM1 CAVIN1 ADA ICOS SP110 CD247 IL2RG IRAK4 RAC2 ICOS MMUT TICAM1 KLLN PIK3R1 WIPF1 NFKB1 RBCK1 CORO1A IRF8 STAT1 XRCC4 MEIS2 EPG5 RTEL1 ZBTB24 IKZF1 NSD2 XIAP EXTL3 NCF1 STIM1 FOXN1 MS4A1 GATA2 COG6 CRKL ISG15 COMT RAG1 NPM1 ATM WAS HBB RNF168 RMRP SKIV2L CDCA7 JMJD1C STAT1 CHD1 FOXN1 PRPS1 RAB27A CDC42 UROS BCL10 SKIV2L DKC1 TNFRSF13C DNMT3B FCGR3A HIRA DKC1 ACTB BCR TNFRSF4 ZBTB24 CDH23 SH2D1A CPLX1 CYBA PGM3 CDC42 SEC23B STK4 TBX1 CD3E CD79B CHD7 POLE ACD IGLL1 TERC IFNGR2 TNFRSF13B CD28 UNC93B1 STX1A EPG5 AKT1 TBK1 SMARCAL1 TERT CR2 IRF8 RMRP IL2RG IL12B IL2RB NFKB1 NCF2 RAG2 WHCR PARN RTEL1 SIK3 SDHB LMNB2 PIK3CD CARD11 FCN3 CAV1 TBX1 TCF3 CYBB PIK3R1 CR2 USF3 PTEN MYC TNFSF12 AK2 MAGT1 CR2 IL2RA LCK RNF168 CD3D NHP2 IKBKG SEC24C PARN NFKB2 IL7R TNFSF12 BTK LYST CUL4B USB1 BUB1B PRKCD CTC1 SPATA5 DKC1 STAT1 GATA1 TINF2 USP8 RAG1 PGM3 TNFRSF1B SDHD MYD88
SNP 0